PERFORMANCE VALIDATION REPORT

INSTRUMENT: D10 HEMOGLOBIN ANALYZER

SERIAL NUMBER: DA5B444607
PTY. CTRL. NO.: FLE000153
DATE PERFORMED: April 3, 2023

Machine performance is verified using the manufacturer's recommendation in validating the functionality of
the instrument.

REFERENCE STANDARD LOT NUMBER EXPIRATION DATE

LYPHOCHECK™ DIABETES CONTROL – Bi-level AA20358-59 June 30, 2024
D10 Hemoglobin A1c Program Calibrator 85841-42 May 31, 2024

COMPONENT CRITERIA RESULT REMARKS

CALIBRATOR 1 5.4 5.4 PASSED
CALIBRATOR 2 10.2 10.2 PASSED
CALIBRATION SLOPE 0.5 - 1.66 1.14 PASSED
CALIBRATION INTERCEPT 0.5 - 2.00 1.03 PASSED
CONTROL LEVEL 1 4.6 - 5.8 5.1 PASSED
CONTROL LEVEL 2 9.2 - 11.6 10.3 PASSED

PERFORMANCE CRITERIA RESULT REMARKS

2
PUMP PRESSURE 15 to75 Kg/cm 29.2 PASSED
PRESSURE FLUCTUATION < 5% of pressure 3% PASSED
RETENTION TIME A1C 0.66 to 1.0 (0.83) 0.85 PASSED
RETENTION TIME AO 1.368 to 1.54 (1.46) 1.4 PASSED
BASE LINE Flat and around 0.02 0.022 flat PASSED
LEAK TEST Should be no leak at pump running at 1.5 ml/min PASSED

General Remarks:
Machine is working properly

PERFORMED BY:

Juan Miguel S. Torsuela

(Signature Over Printed Name)

REVIEWED BY:
Juan Christian Nucum

(Signature Over Printed Name)

Immediate Superior

FM-TS-841, Effectivity Date: November 18, 2022, Issue 1, Rev. 3