TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM

K072714 · Roche Diagnostics Corp. · LCP · Apr 18, 2008 · Hematology

Device Facts

• Record ID: K072714
• Device Name: TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM
• Applicant: Roche Diagnostics Corp.
• Product Code: LCP · Hematology
• Decision Date: Apr 18, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The Tina-Quant Hemoglobin A1c Gen.2 test is in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 800 analyzers for the quantitative determination of percent hemoglobin A1c in hemolysate or whole blood. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Device Story

Tina-Quant Hemoglobin A1c Gen.2 Test System; in vitro diagnostic assay for quantitative HbA1c measurement in human whole blood. Modification extends measuring range from 0.3-2.6 g/dL to 0.3-3.4 g/dL HbA1c. Utilizes immunoturbidimetric principle; automated analysis on Roche clinical chemistry analyzers. Used in clinical laboratory settings by trained personnel. Output provides HbA1c concentration for monitoring glycemic control in patients with diabetes. Modification includes validation for potassium fluoride/Na2-EDTA anticoagulant use.

Clinical Evidence

Bench testing only. Verification and validation activities performed per design control procedures to confirm performance within the extended measuring range (0.3-3.4 g/dL) and compatibility with potassium fluoride/Na2-EDTA anticoagulant.

Technological Characteristics

Turbidimetric inhibition immunoassay (TINIA). Reagents: R1 (MES/TRIS buffer, sheep anti-HbA1c antibody), R2 (polyhapten modified with aminodextran). Bichromatic photometric detection. Compatible with Roche Integra/cobas clinical chemistry analyzers. Automated on-board sample pretreatment. Measuring range 0.3-3.4 g/dL HbA1c (Integra 800/800 CTS).

Indications for Use

Indicated for the quantitative determination of percent hemoglobin A1c in whole blood or hemolysate derived from whole blood on Roche clinical chemistry analyzers to monitor long-term blood glucose control in individuals with diabetes mellitus.

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.

Predicate Devices

• Tina-Quant Hemoglobin A1c Gen.2 Test System (K052464)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER k072714

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Reserved Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary) for the Tina-Quant Hemoglobin A1c Gen.2 Test System:

1. The name and 510(k) number of Roche Diagnostics Corp.'s Previously Cleared Device, Tina-Quant Hemoglobin A1c Gen.2 Test System, cleared under k052464. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION (S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was to extend the measuring range from 0.3 - 2.6 g/dL to 0.3 - 3.4 g/dL HbA1c. Additional information was provided on previous labeling changes for a new anticoagulant potassium fluoride/Na2-EDTA.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.