D-10 Hemoglobin Testing System

General Specifications LIS Specifications

Dimensions
■ Bidirectional capability

W x D x H . . . . . . . . . . . . . . . . . . 402 x 534 x 495 mm (15.8 x 21.0 x 19.5 in.)

■ LIS transmissions can be sent manually or automatically

Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 kg (66.1 lb.)

■ Chromatogram PNG and/or patient report PDF can be sent
manually or automatically to a network folder
Operating Environment
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15–30ºC Stored Data Files
■ 10,000 results (additional storage in onboard archive directory)
Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20–80%, non-condensing
Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,000 m (6,562 ft.) max Sample Handling Specifications
Heat Generation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,010 BTU/hr. max Sample Throughput
■ HbA1c – 20 injections HbA2/F/A1c – 10 injections
Power Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 220 VA max ■

per hour, 3 minutes per hour, 6 minutes

Power Input Requirements . . . . . . . . . . . . . . . . . . 100–240 VAC; 50–60 Hz
between injections between injections
Sound Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . < 70 dBA
Time to First Result
Detector Wavelength . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 415 nm ■ HbA1c – 6 minutes using Auto WarmUp
High Pressure Pump/Proportioning Valve ■ D-10 Dual Kit HbA2/F/A1c – 13 minutes using Auto WarmUp
■ Gradient accuracy ±0.5% at 50% mixing
Sample Preparation (None Required)
■ Gradient precision ±0.5% at 50% mixing ■ No sample mixing ■ No manual sample
User Interface . . . . . . . . . . . . . . . . . . . . . . . . . . Integrated color LCD touchscreen ■ No decapping preparation

Interface Languages Sample Capacity

■ Chinese ■ Japanese ■ 10 samples
■ English ■ Russian ■ 50 samples and continuous loading
■ French ■ Spanish with D-10 Rack Loader (optional)
■ German Specimen Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Whole Blood
Adapter/Ports Sample Tubes
■ Ethernet on RJ45 port ■ Rack feeder connection Sample tubes of different types, including microvials, may be
■ RS232 on DB9 port ■ 6 External USB ports loaded in the same rack and processed in the same run
Liquid Waste Handling Sample tube anticoagulants . . . . . . . . . . . . . . . . . . . . . . . . . . . . K2-EDTA, K3-EDTA
■ One external waste bottle (10 L) Minimum height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69 mm (2.6 in.)
■ Can be connected to a laboratory drain Maximum height . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106 mm (4.2 in.)

Printing Options Primary Tubes

■ Onscreen result review ■ 12 x 75 mm ■ 14 x 100 mm
■ Electronic printing to PDF ■ 13 x 100 mm ■ 16 x 100 mm
■ External thermal printer (available) Microvials . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Conical 1.5 mL sample vials
Sample Stability
Storage Condition D-10 Hemoglobin A1c Program D-10 Dual Program
Room temperature (15–30ºC) Up to 3 days Up to 1 day
2–8ºC Up to 7 days Up to 4 days
-70ºC Up to 12 months NA

Default Minimum Sample Volume* . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 mL

*Adjustable to lower level with FSE visit for special samples

Whole Blood Sample Aspiration Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 µL

Prediluted Sample Aspiration Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250 µL
Supported Barcode Symbologies:
■ Code 39 ■ Codabar ■ Industrial 2 of 5 ■ Interleaved 2 of 5 ■ Code 93 ■ Code 128
Number of Barcode Characters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3–20 alphanumeric

D-10 Rack Loader General Specifications (Optional)

Dimensions Sound Level . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . < 85 dBA D-10 + Rack Loader
W x D x H . . . . . . . . . . . . . . . . . . 310 x 485 x 255 mm (12.2 x 19.1 x 10.0 in.) Power Consumption
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 kg (30.9 lb.) Rack Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 VA max
Operating Environment D-10 + Rack Loader . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320 VA max
Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15–30ºC Sample Capacity
Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20–80%, non-condensing ■ 50 sample continuous loading

Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,000 m (6,562 ft.) max ■ Dedicated STAT function

Power Input Requirements . . . . . . . . . . . . . . . . . . 100–240 VAC; 50–60 Hz Reagent Bottle Tray . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Accepts four 2 L bottles

D-10 Thermal Printer Specifications (Optional)

Dimensions Consumable
W x D x H . . . . . . . . . . . . . . . . . . . . . . . . . . 150 x 155 x 65 mm (5.9 x 6.1 x 2.6 in.) Paper roll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112 mm (4.4 in.) wide
Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 0.8 kg (1.8 lb.)

Reagent Kit – 12000949 D-10 Hemoglobin A1c Program (400 Tests)

Kit Component Specifications
Consumable Quantity Volume Storage Requirements Open Vial Stability Maximum Shelf Life
Buffer 1 2 2,000 mL 15–30°C 8 weeks 24 months
Buffer 2 1 1,000 mL 15–30°C 8 weeks 24 months
Wash/Diluent Solution 1 1,600 mL 15–30°C 8 weeks 24 months
Analytical Cartridge 1 NA 15–30°C 8 weeks or 400 tests 18 months
Calibrator/Diluent Set 1
Calibrator Level 1 3 7 mL (reconstituted) 2–8ºC 7 days 24 months
Calibrator Level 2 3 7 mL (reconstituted) 2–8ºC 7 days 24 months
Calibrator Diluent 1 100 mL 2–8ºC 8 weeks 24 months
Whole Blood Primer 4 1 mL (reconstituted) 2–8ºC 1 day 36 months

Other Components
■ Floppy diskette and CD-ROM with D-10 Dual “Update Kit” program parameters

■ Sample vials – one bag of 50 polypropylene microvials with pierceable caps, 1.5 mL

■ Thermal paper – one roll

220-0109 D-10 Hemoglobin A1c Supplemental Reagent Pack

If the laboratory runs less than 200 tests per month or fewer than four samples per run, a Supplemental Reagent Pack ensures the
laboratory will fully utilize the 400 analytical cartridge.

Consumable Quantity Volume Storage Requirements Open Vial Stability Maximum Shelf Life
Buffer 1 2 2,000 mL 15–30°C 8 weeks 24 months
Buffer 2 1 1,000 mL 15–30°C 8 weeks 24 months
Wash/Diluent Solution 1 1,600 mL 15–30°C 8 weeks 24 months
Performance Specifications
Intended Use:
The D-10 Hemoglobin A1c Program is intended for the quantitative determination of HbA1c in human whole blood using ion-exchange
HPLC on the D-10 Hemoglobin Testing System. HbA1c measurements are used as an aid in the diagnosis of diabetes mellitus, as an
aid to identify patients who may be at risk for developing diabetes mellitus, and for the monitoring of long-term blood glucose control in
individuals with diabetes mellitus. The D-10 Hemoglobin A1c Program is for professional in vitro diagnostic use only.
Total Precision % HbA1c: < 2.2% CV Accuracy (Total Error): ≤ 6%
Linear Range
■ IFCC: 19–182 mmol/mol HbA1c
■ NGSP: 3.9–18.8% HbA1c
Minimum QC Frequency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Once per day
Total Area Range . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0–5.0 million µvolt/second
HbA1c Units Reported . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . IFCC and NGSP
Hemoglobin Variant Windows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . HbE, HbD/HbS, HbC
Hemoglobin Interferences
■ No interference from heterozygous HbS, HbC, HbD, or HbE
– No interference from HbS up to 40%
– No interference from HbC up to 40%
– No interference from HbD up to 40%
– No interference from HbE up to 30%
■ No interference from fetal hemoglobin up to 10%
■ No interference from labile HbA1c up to 6% (or 1,000 mg/dL glucose)
■ No interference from carbamylated hemoglobin up to 3.5% (or 10 mg/dL potassium cyanate)
■ No interference from acetylated hemoglobin at physiologically occurring concentrations
Endogenous Substances
■ No interference from lipemia up to 60 g/L (6,000 mg/dL)
■ No interference from conjugated bilirubin up to 712 µmol/L (60 mg/dL)
■ No interference from unconjugated bilirubin up to 1,026 µmol/L (60 mg/dL)
■ No interference from glucose up to 111 mmol/L (2,000 mg/dL)
■ No interference from rheumatoid factor up to 750 kIU/L (750 IU/mL)
■ No interference from total protein up to 210 g/L (21 g/dL)
There is no interference from common drugs at therapeutic concentrations.

Reagent Kit – 220-0201 D-10 Dual Program (400 Tests for HbA1c or 200 Tests for HbA2/F/A1c)
Kit Component Specifications
Consumable Quantity Volume Storage Requirements Open Vial Stability Maximum Shelf Life
Buffer 1 2 2,000 mL 15–30°C 30 days 24 months
Buffer 2 1 1,000 mL 15–30°C 30 days 24 months
Wash/Diluent Solution 1 1,600 mL 15–30°C 30 days 24 months
Analytical Cartridge 1 NA 15–30°C 8 weeks or 400 tests 18 months
HbA1c Calibrator/Diluent Set 1
Calibrator Level 1 3 7 mL (reconstituted) 2–8ºC 30 days at 2–8ºC 24 months
Calibrator Level 2 3 7 mL (reconstituted) 2–8ºC 30 days at 2–8ºC 24 months
Calibrator Diluent 1 100 mL 2–8ºC 60 days at 2–8ºC 24 months
Whole Blood Primer 4 1 mL (reconstituted) 2–8ºC 1 day at 2–8ºC 36 months
HbA 2 /F/A1c Calibrator/Diluent Set 1
Calibrator Level 1 3 7 mL (reconstituted) 2–8ºC 10 days at 2–8ºC 24 months
Calibrator Level 2 3 7 mL (reconstituted) 2–8ºC 10 days at 2–8ºC 12 months
Calibrator Diluent 1 100 mL 2–8ºC 60 days at 2–8ºC 24 months
Whole Blood Primer 4 1 mL (reconstituted) 2–8ºC 1 day at 2–8ºC 36 months
Other Components
■ Floppy diskette and CD-ROM with D-10 Dual “Update Kit” program parameters

■ Sample vials – one bag of 100 polypropylene microvials with pierceable caps, 1.5 mL
■ Thermal paper – one roll
Performance Specifications
Intended Use:
Short Program – The Bio-Rad D-10 Dual Program is intended for the percent determination of HbA1c in human whole blood using
ion-exchange HPLC.
Extended Program – The Bio-Rad D-10 Dual Program is intended for the percent determination of hemoglobins A2, F, and A1c, and
for the detection of abnormal hemoglobins in human whole blood using ion-exchange HPLC.
The Bio-Rad D-10 Dual Program is for professional in vitro diagnostic use only.

Specification Short Program Extended Program

Total Precision % HbA1c < 1.2% < 1.8%
Total Precision % HbF NA < 3.3%
Low: NA Low: < 5.3%
Total Precision %HbA 2
High: NA High: < 3.1%
Linear Range 18–179 mmol/mol HbA1c 17–178 mmol/mol HbA1c
IFCC
n n NGSP 3.8–18.5% HbA1c 3.7–18.4% HbA1c
% HbA 2 NA 1.5–11.4
% HbF NA 0.8–16.5
Minimum QC Frequency Once per day Once per day
Total Area Range 1.0–5.0 million µvolt/second 1.0–4.0 million µvolt/second
HbA1c Units Reported IFCC and NGSP IFCC and NGSP
Lipemia No interference up to 5,680 mg/dL No interference up to 5,680 mg/dL
Bilirubin 20 mg/dL 20 mg/dL

Hemoglobin Variants
■ Presumptive identification of HbS, HbC, HbD, and HbE in the Extended Program
Hemoglobin Interferences with HbA1c Results
■ No interference from either HbS, HbC, or HbD up to 40% or HbE up to 30% in the Extended Program

■ No interference from fetal hemoglobin up to 10%

■ No interference from labile HbA1c up to 4%
■ No interference from carbamylated hemoglobin up to 3.5%
Hemoglobin Interferences with HbF Results
■ No interference from labile HbA1c up to 2.6%

Endogenous Substance Interferences with HbA1c Results

■ No interference from lipemia up to 5,680 mg/dL

■ No interference from bilirubin up to 20 mg/dL

BIO-RAD and D-10 are trademarks of Bio-Rad Laboratories, Inc. in certain jurisdictions.

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