LIQUI-HEME GLYCO A1C ASSAY

K031296 · Biodiagnostic Intl · LCP · Oct 15, 2004 · Hematology

Device Facts

• Record ID: K031296
• Device Name: LIQUI-HEME GLYCO A1C ASSAY
• Applicant: Biodiagnostic Intl
• Product Code: LCP · Hematology
• Decision Date: Oct 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The BioDiagnostic Intl LIQUI-HEME Glycohemoglobin A1c Test kit is an In Vitro Diagnostic reagent for the quantitative determination of Glycohemoglobin A1c (HbA1c) in human whole blood. The method is an immunological assay. Both the HbA1c and the total hemoglobin are measured. Concentration of HbA1c is calculated as a percentage of the total hemoglobin concentration. Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus. This application has been validated for the Hitachi instrument of clinical chemistry and is intended for use by suitably qualified personnel under appropriate clinical laboratory conditions. Further, this test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional.

Device Story

LIQUI-HEME Glycohemoglobin A1c Assay is an in vitro diagnostic reagent kit; utilizes immunological assay principle to measure HbA1c and total hemoglobin in human whole blood; calculates HbA1c as percentage of total hemoglobin. Used in clinical laboratory settings on Hitachi clinical chemistry instruments; operated by qualified laboratory personnel. Provides quantitative HbA1c percentage to healthcare providers for monitoring long-term glucose control in diabetic patients. Includes optional calibrators and bilevel human-derived controls.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay. Reagents: porcine pepsin, alkaline detergents, polyclonal goat anti-HbA1c antibodies on latex particles, HbA1c agglutination reagent. Energy source: optical absorbance measurement at 600nm. Platform: Hitachi 911 clinical chemistry analyzer. Includes human-derived calibrators and controls.

Indications for Use

Indicated for the quantitative determination of HbA1c in human whole blood to monitor long-term glucose control in individuals with diabetes mellitus. For use by qualified personnel in clinical laboratory settings.

Regulatory Classification

Identification

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
k031296

B. Purpose for Submission:
New Device

C. Analyte:
Glycosylated hemoglobin

D. Type of Test:
Quantitative immunoturbidimetric assay

E. Applicant:
BioDiagnostic International

F. Proprietary and Established Names:
Liqui-Heme Glycohemoglobin A1c Assay

G. Regulatory Information:
1. Regulation section:
21 CFR §862.7470, Assay, glycosylated hemoglobin
21 CFR §862.8165, Calibrator for hemoglobin or hematocrit measurement
21 CFR §862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class II
3. Product Code:
LCP Glycosylated hemoglobin assay
KRZ Calibrator for hemoglobin or hematocrit measurement
JJX Quality control material (assayed and unassayed)
4. Panel:
Hematology (71)

H. Intended Use:
1. Intended use(s):
See below.
2. Indication(s) for use:
"The BioDiagnostic International LIQUI-HEME Glycohemoglobin A1c Test Kit is an in vitro diagnostic reagent for the quantitative determination of glycohemoglobin A1c (HbA1c) in the human whole blood. The method is an immunological assay. Both the concentration of HbA1c and the concentration of total hemoglobin are measured. The reported HbA1c result is calculated as a percentage of the total hemoglobin concentration.

Measurements of percentage HbA1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.

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This application sheet has been developed for the Hitachi instrument of clinical chemistry analyzer and must be used by suitably qualified personnel under appropriate clinical laboratory conditions.

Further, this test kit also includes a set of six calibrators and bilevel (Human) Low and High controls, which are optional."

3. Special condition for use statement(s):
This product is for prescription use only.

4. Special instrument Requirements:
This reagent assay is only intended for the Hitachi 911 analyzer.

I. Device Description:
The device consists of the following liquid components: denaturant reagent (porcine pepsin), total hemoglobin reagent (alkaline detergents), anti-HbA1c antibody reagent (polyclonal goat antibodies on latex particles), HbA1c agglutination reagent, two levels of controls derived from human whole blood that should be processed like samples before use, and six levels of ready-to-use calibrators. Human source material from which this product has been derived has been tested at donor level, with FDA approved or licensed methods, for the HIV 1 and HIV 2 antibodies, Hepatitis B Surface antigen (HBsAg), and HCV antibodies and found to be negative.

J. Substantial Equivalence Information:
1. Predicate device name(s):
Randox Hemoglobin A1c Assay
2. Predicate K number(s):
k021897
3. Comparison with predicate:
The two products are identical in manufacturer, intended use, format, and methodology.

K. Standard/Guidance Document Referenced (if applicable):
None referenced in this submission.

L. Test Principle:
Hemoglobin is lysed from erythrocytes then digested with pepsin to release $\beta$-N-terminal fragments of hemoglobin. These fragments are then bound to an excess of anti-hemoglobin polyclonal antibody; remaining free antibodies are agglutinated with a synthetic polymer carrying various HbA1c $\beta$-N-terminal fragments. The presence of HbA1c in the sample will slow the rate of the agglutination as it competes with the A1c agglutinate for antibody binding sites on the latex. Hence, the increase in absorbance is inversely proportional to the concentration of HbA1c in the sample. Absorbance at $600\mathrm{nm}$ is measured, and a six-point calibration curve is used to calculate percent HbA1c.

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# M. Performance Characteristics (if/when applicable):

1. Analytical performance:
Analytical performance of the Glycohemoglobin A1c Assay was established in k021897.
a. Precision/Reproducibility:
See above.
b. Linearity/assay reportable range:
See above.
c. Traceability, Stability, Expected values (controls, calibrators, or method):
See above.
d. Detection limit:
See above.
e. Analytical specificity:
See above.
f. Assay cut-off:
See above.

2. Comparison studies:
a. Method comparison with predicate device:
The Liqui-Heme Glycohemoglobin A1c Assay, run on the Hitachi 911 analyzer, was compared to BioRad's Variant II Total GHb, another clinical chemistry lab based method, using 54 patient samples. Sample values ranged from 4.3% to 17.2% HbA1c. Below are the parameters of the regression analysis:

| Parameter | Value |
| --- | --- |
| Slope | 0.96 |
| Y-intercept | 0.45 |
| r² | 0.95 |
| n = | 54 |

These parameters were within the sponsor's acceptance criteria.

b. Matrix comparison:
Not applicable. This assay is to be performed only in venous whole blood collected with anticoagulants (EDTA, sodium citrate, or oxalate/fluoride).

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):

4. Clinical cut-off:
Not applicable.

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5. Expected values/Reference range:
The normal range for HbA1c in non-diabetic people is 4 to 6% according to the literature referenced. The American Diabetes Association recommends a goal of <7% for effective management of diabetes and to minimize long-term diabetic complications. A level above 7% suggests that more intensive diabetes management should be considered.

N. Conclusion:
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.