510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION

DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:

k171476

B. Purpose for Submission:

New Device

C. Measurand:

Sodium, Potassium, Chloride

D. Type of Test:

Quantitative, ion selective electrode technology

E. Applicant:

Awareness Technology, Inc.

F. Proprietary and Established Names:

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-)

G. Regulatory Information:

Product
Classification Regulation Section Panel
Code
JGS 21 CFR 862.1665 Sodium Test System
CEM Class II 21 CFR 862.1600 Potassium Test System Clinical
CGZ 21 CFR 862.1170 Chloride Test System Chemistry
21 CFR 862.2160 Discrete Photometric Analyzer (75)
JJE Class I
Chemistry for Clinical Use

H. Intended Use:

1. Intended use(s):

See Indications for use below

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 2. Indication(s) for use:

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an in vitro device intended to be
used for the measurement of ionized Sodium (Na+), Potassium (K+), and Chloride (Cl-)
in serum and lithium heparin venous whole blood samples. The measurements are to be
conducted by a trained professional in a clinical laboratory. For in-vitro diagnostic use
only.

The SelectaLyte Sodium (Na+) assay is intended to measure sodium. Measurements

obtained by this device are used to monitor electrolyte balance in the diagnosis and
treatment of aldosteronism, diabetes insipidus, adrenal hypertension, Addison's disease,
dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving
electrolyte imbalance.

The SelectaLyte Potassium (K+) assay is intended to measure potassium. Measurements

obtained by this device are used to monitor electrolyte balance in the diagnosis and
treatment of disease conditions characterized by low or high blood potassium levels.

The SelectaLyte Chloride (Cl-) assays is intended to measure chloride. Measurements are
used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic
fibrosis and diabetic acidosis.

3. Special conditions for use statement(s):

For in-vitro diagnostic use only

For prescription use only
Not for Point-of-Care Use

4. Special instrument requirements:

SelectaLyte Electrolyte Analyzer, model #3910

I. Device Description:

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) is an automated, microprocessor-

controlled electrolyte analyzer for measurement of Sodium (Na+), Potassium (K+), and
Chloride (Cl-) in serum, and lithium heparin venous whole blood. The instrument features
automatic and on-demand calibration, patient data storage, and interactive LCD touch screen.

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) utilizes ion selective electrodes (ISE) to
measure test samples, and display the results automatically. Each reagent pack contains the
following reagents:

· Cal Standard: 650mL (Na+ 150 mmol/L, K+ 5.0 mmol/L, Cl- 115 mmol/L)
· SLOPE Standard: 125mL (Na+ 100 mmol/L, K+ 2.0 mmol/L, Cl- 70 mmol/L)
· Reference Solution: 125 mL (KCl: 1.2 mol/L)

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J. Substantial Equivalence Information:

1. Predicate device name(s):

AVL 9180 Electrolyte Analyzer

2. Predicate 510(k) number(s):

k961458

3. Comparison with predicate:

Similarities and Differences

Item SelectaLyte Electrolyte Analyzer AVL 9180 Electrolyte Analyzer
(Na+, K+, Cl-) (Predicate Device k961458)
(Candidate Device k171476)
Intended Use For in vitro diagnostic use in the Same
quantitative determination of
sodium, potassium and chloride.
Method Principle Ion Selective Electrode with Same
potentiometric method
Standardization Na: Flame photometric with NIST Same
reference standards
K: Flame photometric method with
NIST reference serum
Cl: Coulometric method with NIST
standards
Analytical Na: 40 – 205 mmol/L Same
Measuring Range: K: 1.5 – 15.0 mmol/ L
Cl: 50 – 200 mmol/ L
Sample Type whole blood, serum whole blood, serum or plasma,
urine
Electrolytes Sodium (Na+), Potassium (K+), Sodium (Na+), Potassium (K+),
Measured and Chloride (Cl-) Chloride (Cl-), Lithium(Li+),
Calcium(Ca2+)
Sample Volume 85 μL 95 μL
Reagent Pack Cal Standard: 650mL Standard A 350 mL
SLOPE Standard: 125mL Standard B 85 mL
Reference solution: 125 mL Reference Solution 85 mL
Waste bag Waste bag

K. Standard/Guidance Document Referenced (if applicable):

· CLSI EP05-A2: Evaluation of Precision of Quantitative Measurement Procedures;

Approved Guideline.

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 · CLSI EP06-A: Evaluation of the Linearity of Quantitative Measurement Procedures:
A Statistical Approach; Approved Guideline.
· CLSI EP07-A2: Interference Testing in Clinical Chemistry; Approved Guideline.
· CLSI EP09-A3: Measurement Procedure Comparison and Bias Estimation Using
Patient Samples; Approved Guideline.
· CLSI EP 21-A: Evaluation of Total Analytical Error for Clinical Laboratory
Methods; Approved Guideline.
· CLSI GP 41-A6: Procedures for the Collection of Diagnostic Blood Specimens by
Venipuncture; approved standard.

L. Test Principle:

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) measures sodium, potassium, and
chloride in dialysate using ion selective electrode technology. The sodium electrode contains
a glass tube, specially formulated to be sensitive to sodium ions. The potassium electrode
incorporates neutral carrier ionophore membranes which are highly selective for their
respective ions. The chloride electrode contains an ionophore covalently bound to a substrate
which is sensitive to negatively charged ions. The potential of each electrode is measured
relative to a fixed, stable reference established by a silver/silver chloride electrode in
concentrated salt solution. The measured potential varies with the concentration of the ion
sensed by the electrode.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Precision testing was performed in accordance with CLSI EP05-A2 guideline. Serum
sample precision was evaluated by testing three levels of serum pools in two
replicates per run, two runs per day for 20 days on two instruments by multiple
operators. Whole blood sample precision was evaluated by testing three levels of
whole blood samples on two instruments with calibrations after 10 consecutive
replicates to obtain a total of 40 results per sample. The data obtained from two
instruments are very similar and a representative data set is shown in the tables
below:

Precision results for Sodium Matrix: Serum

Sample Within Run Within Lab
Mean
N SD CV SD CV
(mmol/L)
(mmol/L) (%) (mmol/L) (%)
Serum 1 80 95.2 0.27 0.29% 0.78 0.82%
Serum 2 80 134.7 0.33 0.25% 0.72 0.54%
Serum 3 80 178.8 0.28 0.16% 1.51 0.84%

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 Precision results for Potassium Matrix: Serum
Sample Within Run Within Lab
Mean
N SD CV SD CV
(mmol/L)
(mmol/L) (%) (mmol/L) (%)
Serum 1 80 2.77 0.02 0.64% 0.02 0.79%
Serum 2 80 4.01 0.02 0.52% 0.03 0.78%
Serum 3 80 6.59 0.02 0.24% 0.06 0.97%

Precision results for Chloride Matrix: Serum

Sample Within Run Within Lab
Mean
N SD CV SD CV
(mmol/L)
(mmol/L) (%) (mmol/L) (%)
Serum 1 80 63.2 0.29 0.46% 0.58 0.91%
Serum 2 80 90.1 0.31 0.34% 0.74 0.82%
Serum 3 80 114.4 0.3 0.26% 1.06 0.93%

Precision results for Sodium Matrix: Whole Blood

Within Run Within Lab
Mean
Sample N SD SD
(mmol/L) CV (%) CV (%)
(mmol/L) (mmol/L)
Whole blood 1 40 98.9 0.69 0.70% 0.42 0.43%
Whole blood 2 40 136.8 0.58 0.42% 0.32 0.24%
Whole blood 3 40 161.0 0.35 0.22% 0.23 0.14%

Precision results for Potassium Matrix: Whole Blood

Within Run Within Lab
Mean
Sample N SD SD
(mmol/L) CV (%) CV (%)
(mmol/L) (mmol/L)
Whole blood 1 40 2.14 0.03 1.33% 0.03 1.27%
Whole blood 2 40 3.29 0.07 2.03% 0.07 2.07%
Whole blood 3 40 7.78 0.06 0.79% 0.08 1.07%

Precision results for Chloride Matrix: Whole Blood

Within Run Within Lab
Mean
Sample N SD SD
(mmol/L) CV (%) CV (%)
(mmol/L) (mmol/L)
Whole blood 1 40 69.5 0.88 1.26% 0.57 0.81%
Whole blood 2 40 104.4 0.95 0.91% 0.52 0.50%
Whole blood 3 40 129.9 0.7 0.54% 0.53 0.40%

b. Linearity/assay reportable range:

The linearity studies were performed following the CLSI EP06-A guideline. For the
three electrolytes, ten to eleven equally spaced concentrations covering the
measurement range were prepared by mixing high and low concentration samples.

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 Four replicates were measured for each sample. The observed values were plotted
against the expected values and linear regression analysis was performed. The
summary results are provided in the table below.

Analyte in Claimed Measuring Sample Range

Slope Intercept r
Serum Range (mmol/L) Tested (mmol/L)
Sodium 40 to 205 35.9 - 203.5 0.988 -3.81 0.9988
Potassium 1.5 to 15.0 1.26 - 19.62 1.010 -0.14 0.9999
Chloride 50 to 200 30.1 - 202.3 0.999 -1.32 0.9999
Analyte in Claimed Measuring Sample Range
Slope Intercept r
Whole Blood Range (mmol/L) Tested (mmol/L)
Sodium 40 to 205 33 - 217.5 1.006 -4.28 0.9995
Potassium 1.5 to 15.0 1.45 - 18.49 1.008 -0.41 0.9993
Chloride 50 to 200 33.4 - 214.6 1.000 0.35 1.0000

The results of the linearity study support the sponsor’s claimed measuring ranges (as
described in the table above).

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability

The SelectaLyte Na assay is traceable to a flame emission spectrophotometry

reference method, which uses reference materials from the National Institute of
Standards and Technology (NIST).

The SelectaLyte K assay is traceable to a flame emission spectrophotometry reference

method, which uses reference materials from the NIST.

The SelectaLyte Cl assay is traceable to a coulometric reference method, which uses

reference materials from the NIST.

d. Detection limit:

Reportable ranges were determined based on the linearity studies (see above, M.1.b).

e. Analytical specificity:

Interference studies were performed according to CLSI EP07-A2 guideline to

determine the effects from potential interferents on the ISE assays. Various
concentrations of interferents were spiked into two levels (low and high) of each
analyte in serum or whole blood. Testing was performed in four replicates per level
using one reagent lot on one instrument. The sponsor states that interference is
considered to be non-significant if the bias between the tested and control samples are
within 4.0, 0.20 and 3.1 mmol/L for Na+, K+ and Cl-, respectively.

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The results of the interference study for serum samples are summarized below:
Highest concentration tested that did not
Analyte Interferent
show significant interference
Bilirubin Conjugate 1000.0 mg/dL
Cholesterol 503.1 mg/dL
Serum Hemoglobin 200.0 mg/dL
Sodium Isoniazid 4.0 mg/dL
Lithium Acetate 21.1 mg/dL
Magnesium Acetate 213.6 mg/dL
Metronidazole 12.0 mg/dL
Bilirubin Conjugate 1000.0 mg/dL
Cholesterol 503.1 mg/dL
Serum Hemoglobin 200.0 mg/dL
Potassium Isoniazid 4.0 mg/dL
Lithium Acetate 21.1 mg/dL
Magnesium Acetate 213.6 mg/dL
Metronidazole 12.0 mg/dL
Sodium Fluoride 0.33 mg/dL
Sodium Heparin 3000.0 U/L
Sodium Iodide* 5.6 mg/dL
Triglycerides 2364.3 mg/dL
Vancomycin 10.3 mg/dL
Acetylcysteine 166.5 mg/dL
Acetylsalicylic Acid 65.2 mg/dL
Serum Ampicillin 5.3 mg/dL
Chloride Bilirubin Conjugate 1000.0 mg/dL
Cefoxitin 69.5 mg/dL
Cholesterol 200.0 mg/dL
Doxycycline 3.2 mg/dL
EDTA 0.13 mg/dL
Hemoglobin 200.0 mg/dL
Ibuprofen 55.4 mg/dL
Isoniazid 4.0 mg/dL
Lithium Acetate 21.1 mg/dL
Magnesium Acetate 213.6 mg/dL
Metronidazole 12.0 mg/dL
Paracetamol 20.0 mg/dL
pH (High) ~8.0
Potassium Thiocyanate 25.1 mg/dL
Rifampicin 6.4 mg/dL
Sodium Bicarbonate 294.0 mg/dL
Sodium Bromide* 24.1 mg/dL
Sodium Fluoride 0.33 mg/dL
Sodium Heparin 3000.0 U/L

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 Highest concentration tested that did not
Analyte Interferent
show significant interference
Sodium Iodide 5.6 mg/dL
Triglycerides 2364.3 mg/dL
Vancomycin 10.3 mg/dL
*Continued Interference

Serum Interference Observations:

· Cholesterol showed interference with Chloride assay at concentrations 503
mg/dL, 377 mg/dL, 251 mg/dL with a bias greater than 3.4 mmol/L.
· Potassium Thiocyanate showed interference with Chloride assay at
concentrations 66.9 mg/dL, 33.4 mg/dL, with a bias greater than 4.3 mmol/L.
· Sodium Bromide showed interference with Chloride assay at all
concentrations tested with a bias greater than 4.5 mmol/L.
· Sodium Fluoride showed interference with Chloride and Potassium assays at
concentration 0.44 mg/dL with a bias of 12.4 mmol/L for chloride and 0.64
mmol/L for potassium.
· Sodium Iodide showed interference with Chloride and Potassium assays at
concentration 44.8 mg/dL, 22.5 mg/dL, 11.2mg/dL, with a bias of 3.3 mmol/L
for chloride and continued interference for potassium with a bias greater than
0.24 mmol/L.

The interference study for whole blood samples are summarized below:

Highest concentration tested that did not

Analyte Interferent
show significant interference
Whole Blood Acetone 69.7 mg/dL
Sodium Acetylsalicylic Acid 59.1 mg/dL
Benzalkonium Chloride 0.67 mg/dL
Bilirubin Conjugate 1000.0 mg/dL
Bilirubin, Total 20.0 mg/dL
Cholesterol 503.1 mg/dL
Creatinine 5.0 mg/dL
Ethanol 399.9 mg/dL
Hemoglobin 200.0 mg/dL
Potassium Thiocyanate 66.9 mg/dL
Salicylic Acid 59.9 mg/dL
Whole Blood Acetone 69.7 mg/dL
Potassium Acetylsalicylic Acid 59.1 mg/dL
Bilirubin Conjugate 1000.0 mg/dL
Bilirubin, Total 10.0 mg/dL
Cholesterol 503.1 mg/dL
Creatinine 5.0 mg/dL
Ethanol 399.9 mg/dL

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 Highest concentration tested that did not
Analyte Interferent
show significant interference
Hemoglobin 150.0 mg/dL
Salicylic Acid 15.0 mg/dL
Sodium Bromide 48.2 mg/dL
Whole Blood Acetone 69.7 mg/dL
Chloride Acetylsalicylic Acid 59.1 mg/dL
Bilirubin Conjugate 1000.0 mg/dL
Bilirubin, Total 20.0 mg/dL
Cholesterol 251.6 mg/dL
Creatinine 5.0 mg/dL
Ethanol 399.9 mg/dL
Hemoglobin 200.0 mg/dL
Potassium Thiocyanate* 8.4 mg/dL
Salicylic Acid 45.0 mg/dL
Sodium Bromide* 24.1 mg/dL
Sodium Iodide 11.3 mg/dL
*Continued Interference

Whole Blood Interference Observations:

· Bilirubin, Total showed interference with Potassium assay at concentrations
20 mg/dL, 15 mg/dL, with a bias greater than 0.22 mmol/L.
· Cholesterol showed interference with Chloride assay at concentrations 503
mg/dL, 377 mg/dL, with a bias greater than 3.6 mmol/L.
· Hemoglobin showed interference with Potassium assay at concentrations 200
mg/dL, 377 mg/dL, 251 mg/dL with a bias greater than 0.27 mmol/L.
· Potassium Thiocyanate showed interference with Chloride assay at all
concentrations tested with a bias greater than 4.7 mmol/L.
· Salicylic Acid showed interference with Chloride assay at concentration 60
mg/dL with a bias greater than 8.5 and Potassium assay at concentrations 60
mg/dL, 45 mg/dL, 29 mg/dL, 22.5 mg/dL with a bias greater than 0.24
mmol/L.
· Sodium Bromide showed interference with Chloride assay at all
concentrations tested with a bias greater than 22.1 and Potassium assay at
concentrations 386 mg/dL, 193 mg/dL, 93.5 mg/dL, 22.5 mg/dL with a bias
greater than 0.32 mmol/L.
· Sodium Iodide showed interference with Chloride assay at concentration
44.8mg/dL with a bias of 8.2 mmol/L.
· Avoid Hemolyzed samples for potassium. Hemolyzed samples may give
incorrect elevated potassium.

f. Assay cut-off:

Not Applicable

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2. Comparison studies:

a. Method comparison with predicate device:

Method comparison studies were performed following CLSI EP09-A3. One hundred
patient samples for each sample matrix type were run in singlet on one SelectaLyte
Electrolyte Analyzer and the results were compared to those obtained on the predicate
device (AVL 9180 Electrolyte Analyzer). Among the samples tested for each analyte,
10% of the samples were spiked or diluted to fully span the claimed measuring range
of each analyte. The ordinary linear regression analyses for the three electrolytes are
summarized below:

Range tested
Analyte in Serum Slope Intercept r2 N
(mmol/L)
Sodium 0.971 2.79 0.9869 100 43.3-194.2
Potassium 1.014 -0.17 0.9959 100 1.51-14.72
Chloride 0.950 6.14 0.9854 100 55-192.6
Range tested
Analyte in Whole Blood Slope Intercept r2 N (mmol/L)
Sodium 1.002 -1.60 0.9865 100 43.3-204.6
Potassium 1.028 -0.21 0.9946 100 1.58-14.84
Chloride 0.953 4.92 0.9806 100 53-192.2

b. Matrix comparison:

Not Applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not Applicable

b. Clinical specificity:

Not Applicable

c. Other clinical supportive data (when a. and b. are not applicable):

Not Applicable

4. Clinical cut-off:

Not Applicable

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 5. Expected values/Reference range:

Reference ranges of Na+, K+, and Cl- are cited from literature1:

Sodium: 136 – 145 mmol/L

Potassium: 3.5 – 5.0 mmol/L
Chloride: 98 – 106 mmol/L
1
Mosby's Diagnostic and Laboratory Test Reference 8ed. 2017

N. Instrument Name:

SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-), model #3910

O. System Descriptions:

1. Modes of Operation:

Does the applicant’s device contain the ability to transmit data to a computer, webserver,
or mobile device?

Yes ________ or No X

Does the applicant’s device transmit data to a computer, webserver, or mobile device
using wireless transmission?

Yes ________ or No X

2. Software:

The software for the SelectaLyte Electrolyte Analyzer system is determined to have a
moderate level of concern.

FDA has reviewed applicant’s Hazard Analysis and software development processes for
this line of product types:

Yes X or No ________

3. Specimen Identification:

Manual entry

4. Specimen Sampling and Handling:

A sample probe in the SelectaLyte Electrolyte Analyzer aspirates 85 µL samples directly

from sample tubes.

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 5. Calibration:

The SelectaLyte Electrolyte Analyzer (Na+, K+, Cl-) performs a 2-point calibration every
4 hours or by request with a known fluid from the SelectaLyte Reagent Pack. A 1-point
calibration is performed automatically during each measurement.

6. Quality Control:

The sponsor recommends on their labeling that “Use only Selectalyte Quality Control Kit
Tri Level for monitoring performance.” and “Follow government regulations or
accreditation requirements for quality control frequency. At least once each day of use,
analyze 2 levels (low and high) of commercially available quality control (QC) material
with known Na, K, Cl concentrations.”

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The

“Performance Characteristics” Section above:

Not applicable

Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a

substantial equivalence decision.

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