(59 days)
This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes The COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the Roche COBAS INTEGRA 800 clinical chemistry analyzer.
The COBAS INTEGRA 800 Tima-quant HbA1cDx Gen.2 assay consists of two working reagents (R1 and R2) and an Hemolyzing reagent. The R1 reagent consists of antibody reagent, MES buffer: 0.025 mol/L; TRIS buffer: 0.015molL, ph6.2; HbA1c antibody (bovine serum): ≥0.5 mg/ml; stabilizers; preservatives (liquid). R2 reagent (Polyhapten reagent) consists of MES buffer: 0.025 mol/L; TRIS buffer: 0.015 moVL, ph 6.2, HbA1c polyhapten: ≥ 8ug/mL; stabilizers; preservatives (liquid)
The Roche Tina-quant Hemoglobin A1c Gen. 2 consists of two application types: The Whole Blood application uses an automated on-board sample pretreatment with hemolyzing reagent. The Hemolysate application consists of a manual pretreatment step which is performed using the hemolyzing reagent before the sample is placed on the analyzer.
Calibrators (Roche Cfas HbA1c) and controls (Roche PreciControl HbA1c norm and path) are recommended for use with this device. The calibrators and controls were previously cleared under 510(k) numbers K052101 and K103099 respectively.
Here's a summary of the acceptance criteria and the study detailing the device performance for the COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay, based on the provided decision summary:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document explicitly states the acceptance criteria for Total Error. For other categories, the "acceptance criteria" are implied by the performance demonstrated in the studies and the conclusions drawn (e.g., "no significant interference").
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Precision | |
| Hemolysate Application: Total CV ≤ 1.4% for concentrations 5.2% - 11.9% HbA1c | Hemolysate Application (Combined): Total CV ranged from 1.2% to 1.4% across HbA1c levels 5.18% to 11.85% |
| Whole Blood Application: Total CV ≤ 1.5% for concentrations 5.3% - 12.1% HbA1c | Whole Blood Application (Combined): Total CV ranged from 0.9% to 1.5% across HbA1c levels 5.25% to 12.09% |
| Linearity/Reportable Range | The reportable range for this device is 4.2-20.1% HbA1c (DCCT/NGSP); 23-196 mmol/mol HbA1c (IFCC), established previously under K072714. |
| Traceability | Certified with the National Glycohemoglobin Standardization Program (NGSP). |
| Analytical Specificity (Endogenous Interference) - Significant Interference defined as > ± 7% recovery | No significant interference observed for: |
- Lipemia (Intralipid): up to 800 mg/dL
- Conjugated Bilirubin: up to 60 mg/dL
- Unconjugated Bilirubin: up to 60 mg/dL
- Rheumatoid Factor: up to 750 IU/mL
- Glucose: up to 1000 mg/dL
- Total Protein: up to 21 g/dL |
| Analytical Specificity (Drug Interference) - Significant Interference defined as > ± 7% recovery | No significant interference observed for a list of 14 common drugs (e.g., Acetylcystein, Ampicillin-Na, Ascorbic Acid, etc.) at specified concentrations. |
| Analytical Specificity (Cross Reactivity with Hemoglobin Derivatives) - Significant Interference defined as > ± 7% recovery | No cross reactions at physiologically occurring concentrations with HbA0, HbA1a, HbA1b, acetylated hemoglobin, carbamylated hemoglobin, glycated albumin, and labile HbA1c. |
| **Analytical Specificity (Hemoglobin Variant Interference - Bias
§ 862.1373 Hemoglobin A1c test system.
(a)
Identification. A hemoglobin A1c test system is a device used to measure the percentage concentration of hemoglobin A1c in blood. Measurement of hemoglobin A1c is used as an aid in the diagnosis of diabetes mellitus and as an aid in the identification of patients at risk for developing diabetes mellitus.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The device must have initial and annual standardization verification by a certifying glycohemoglobin standardization organization deemed acceptable by FDA.
(2) The premarket notification submission must include performance testing to evaluate precision, accuracy, linearity, and interference, including the following:
(i) Performance testing of device precision must, at a minimum, use blood samples with concentrations near 5.0 percent, 6.5 percent, 8.0 percent, and 12 percent hemoglobin A1c. This testing must evaluate precision over a minimum of 20 days using at least three lots of the device and three instruments, as applicable.
(ii) Performance testing of device accuracy must include a minimum of 120 blood samples that span the measuring interval of the device and compare results of the new device to results of a standardized test method. Results must demonstrate little or no bias versus the standardized method.
(iii) Total error of the new device must be evaluated using single measurements by the new device compared to results of the standardized test method, and this evaluation must demonstrate a total error less than or equal to 6 percent.
(iv) Performance testing must demonstrate that there is little to no interference from common hemoglobin variants, including Hemoglobin C, Hemoglobin D, Hemoglobin E, Hemoglobin A2, and Hemoglobin S.
(3) When assay interference from Hemoglobin F or interference with other hemoglobin variants with low frequency in the population is observed, a warning statement must be placed in a black box and must appear in all labeling material for these devices describing the interference and any affected populations.