TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST

K052464 · Roche Diagnostics Corp. · LCP · Sep 30, 2005 · Hematology

Device Facts

• Record ID: K052464
• Device Name: TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST
• Applicant: Roche Diagnostics Corp.
• Product Code: LCP · Hematology
• Decision Date: Sep 30, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.7470
• Device Class: Class 2

Indications for Use

The Tina-Quant Hemoglobin A 1c Gen.2 test is an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin Alc in whole blood. HbA1c results are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Device Story

Tina-Quant Hemoglobin A1c Gen.2 is an in vitro diagnostic reagent system for automated analyzers (e.g., Integra 800). It processes anticoagulated whole blood specimens via two application modes: manual hemolysate or automated on-board whole blood pretreatment. The system utilizes a turbidimetric inhibition immunoassay (TINIA) to measure HbA1c; antigen-antibody complexes form, and excess antibody aggregates with polyhapten to create insoluble complexes. Total hemoglobin is measured bichromatically in the same channel during preincubation. The instrument calculates % HbA1c from the HbA1c/Hb ratio. Results assist clinicians in monitoring long-term glycemic control in diabetic patients, providing improved precision and interference resistance compared to the predicate.

Clinical Evidence

Bench testing only. Performance data includes precision (within-run 0.6-1.0%, between-day 0.8-1.3%), linearity (0.3-2.6 g/dL HbA1c), and lower detection limits (0.02 g/dL HbA1c). Interference studies confirmed robustness against icterus, lipemia (up to 800 mg/dL), rheumatoid factor, and glucose. Standardized against IFCC reference method.

Technological Characteristics

In vitro diagnostic reagent system; TINIA principle; bichromatic photometric Hb measurement; automated on-board pretreatment; reagents include MES/TRIS buffers, polyclonal anti-HbA1c (sheep), and aminodextran-modified polyhapten; standardized to IFCC reference method; compatible with automated analyzers (e.g., Integra 800).

Indications for Use

Indicated for the quantitative determination of percent hemoglobin A1c in whole blood 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 (K934070)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

ODE Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER K052464

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (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 (labeling changes are permitted as long as they do not affect the intended use).
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 for the test system is being applied to the Integra 800 analyzer, hemoglobin determinations are no longer performed in a separate channel but instead occur during the sample preincubation step of the HgbA1c reaction, is an option for on-board, automatic sample pretreatment with hemolyzing reagent, calibrator is provided at a single level and is automatically diluted on-board the analyzer. Performance characteristics have changed including lower detection limit, linearity, precision and interference claims. Reagent composition and kit configuration changes have been made as follows: elimination of separate reagent for hemoglobin, addition of a second hemolyzing reagent (Hemolyzing Reagent Gen.2) which is four times the concentration of the other hemolyzing reagent, calibrator provided separately. New product labeling to reflect the assay changes.

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