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510(k) Data Aggregation
(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 < ± 7%) | No significant interference for: - HbS: (≤42%), Bias observed: 4.64% (at ~6.0% HbA1c), 4.02% (at ~9.0% HbA1c) - HbC: (≤42%), Bias observed: -2.09% (at ~6.0% HbA1c), -3.34% (at ~9.0% HbA1c) - HbE: (≤33%), Bias observed: 0.47% (at ~6.0% HbA1c), -4.29% (at ~9.0% HbA1c) - HbD: (≤42%), Bias observed: -2.57% (at ~6.0% HbA1c), -0.86% (at ~9.0% HbA1c) - HbA2: (≤7%), Bias observed: 1.19% (at ~6.0% HbA1c), -6.58% (at ~9.0% HbA1c) |
| Analytical Specificity (Hemoglobin Variant Interference - Warnings for HbF) | Significant interference observed for HbF. Bias exceeds -7% when HbF content exceeds +7%. Device labeling includes a prominent boxed warning. |
| Accuracy (Method Comparison with Reference Method) - Little to no bias | Hemolysate Application Bias: - 5.0% Decision Level: 0.173 (3.46%) - 6.5% Decision Level: 0.077 (1.18%) - 8.0% Decision Level: -0.019 (-0.23%) Whole Blood Application Bias: - 5.0% Decision Level: 0.061 (1.22%) - 6.5% Decision Level: 0.084 (1.29%) - 8.0% Decision Level: 0.107 (1.34%) |
| Total Error (TE) ≤ 6% | Hemolysate Application TE: - 5.2% Decision Level: 5.7% - 6.5% Decision Level: 3.8% - 8.0% Decision Level: 2.6% Whole Blood Application TE: - 5.2% Decision Level: 4.2% - 6.5% Decision Level: 4.1% - 8.0% Decision Level: 4.1% |
2. Sample Size Used for the Test Set and Data Provenance
- Precision Study:
- Whole Blood/Hemolysate: 4 patient samples at targeted HbA1c values (5%, 6.5%, 8%, 10%) and 2 controls (PreciControl HbA1c norm and path).
- Total measurements: 756 measurements per sample type (whole blood and hemolysate applications each had this number of total measurements across the study setup).
- Data Provenance: Not explicitly stated, but likely from a centralized lab for controlled testing (generally for regulatory submissions, these are from controlled environments rather than diverse real-world settings unless otherwise specified). It's a prospective study for a device performance evaluation.
- Endogenous/Drug Interference: Pooled whole blood samples (HbA1c ~6.5% and ~8.9% or ~8.5%) spiked with interferents.
- Hemoglobin Variant Interference: 110 samples known to contain Hemoglobin variants S, C, E, D, A2, and F.
- Method Comparison (Accuracy): 141 variant-free samples, ranging from 4.7% to 12.2% HbA1c.
- Data Provenance: Not explicitly stated, but these are patient samples evaluated against a reference method. It's a prospective study of device performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts to establish ground truth in the traditional sense (e.g., for image interpretation or disease diagnosis). Instead, analytical ground truth was established through:
- Reference Methods: For accuracy studies, the device was compared to a secondary NGSP reference laboratory using a cleared HPLC-based HbA1c assay. This reference laboratory and its methods are considered the functional "ground truth" for HbA1c measurements. HPLC (High-Performance Liquid Chromatography) is a widely accepted and highly accurate method for HbA1c.
- Known Sample Characteristics: For precision, linearity, and interference studies, samples were either characterized beforehand (e.g., specific HbA1c levels, known variant presence, spiked interferents) or measured against established analytical standards.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative diagnostic assay, not a subjective interpretation task requiring adjudication by multiple readers or experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is a study for an in vitro diagnostic device (a lab test), not an AI-assisted diagnostic imaging or interpretation system that would typically involve human readers.
6. Standalone (Algorithm Only) Performance
Yes, the studies described are standalone performance evaluations of the COBAS INTEGRA 800 Tina-quant HbA1cDx Gen.2 assay as a direct measurement device. The algorithm (immunoassay) itself is evaluated without human-in-the-loop performance modifications or assistance.
7. Type of Ground Truth Used
- Expert Consensus: Not applicable.
- Pathology: Not applicable.
- Outcomes Data: Not applicable for establishing analytical ground truth, but clinical guidelines and scientific literature were cited as "clinical justification" for the use of HbA1c in diagnosis.
- Reference Method / Certified Standards: The primary ground truth for quantitative measurements, such as HbA1c, is established through comparison to a reference method certified by a standardization program (NGSP in this case). For interference studies, samples with known concentrations of interferents or known hemoglobin variants were used.
8. Sample Size for the Training Set
Not applicable. This is an immunoassay, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the assay refers to its development and optimization based on chemical principles, reagent formulation, and calibration.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this device does not use a "training set" in the context of machine learning. The "ground truth" for the development and calibration of the assay would typically involve highly characterized samples, reference materials, and established analytical methods used during the assay's research and development phase to ensure its chemical and analytical properties meet performance specifications.
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