(206 days)
For the quantitative determination of percent hemoglobin A1c in whole blood (or hemolysate derived from whole blood) on Roche clinical chemistry analyzers. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.
With the Tina-Quant Hemoglobin A1c Gen.2 test system, the anticoagulated whole blood specimen is hemolyzed prior to determination of HbA1c by an turbidimetric inhibition immunoassay (TINIA). Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbA1c from the HbA1c/ Hb ratio according to a user selected protocol.
Here's a summary of the acceptance criteria and study information for the Tina-Quant® Hemoglobin A1c Gen.2 Test System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on modifications to an already cleared device (K052464). The acceptance criteria for the new features or extended parameters are shown below, along with the reported performance where available.
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Measuring Range (Integra 800/800 CTS) | 0.3 - 3.4 g/dL HbA1c (for HbA1c); 4-35 g/dL Hb (for Hb) | Modified Device (Integra 800/800 CTS): 0.3 - 3.4 g/dL HbA1c, 4-35 g/dL Hb (This is the expanded range, which is the acceptance criterion itself for this modification). Predicate Device (Integra 800): 0.3-2.6 g/dL HbA1c, 4-35 g/dL Hb |
| Endogenous Interferences (Whole blood application only) | No significant interference (bias within ± 10%) for: |
- Lipemia (up to 800 mg/dL Intralipid)
- Bilirubin (up to 30 mg/dL Bilirubin/ditaurobilirubin)
- Rheumatoid factor (up to 350 IU/mL RF)
- Glycemia (up to 1000 mg/dL glucose) | Reported: No significant interference (bias within ± 10%) up to:
- 800 mg/dL Intralipid
- 30 mg/dL Bilirubin/ditaurobilirubin
- 350 IU/mL RF
- 1000 mg/dL Glucose |
| Anticoagulant (Potassium fluoride/Na2-EDTA) | Reagent-specific criteria: - Mean deviation of all samples:
§ 864.7470 Glycosylated hemoglobin assay.
(a)
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.(b)
Classification. Class II (performance standards).