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510(k) Data Aggregation
(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: <= 0.2% HbA1c - Maximum deviation of single sample: <= 0.75% HbA1c General criteria for unlimited acceptance: - Median deviation of recovery against reference for all sample pairs <= 5% recovery - Maximum deviation of recovery of 80% of all sample pairs <= 10% recovery (up to 20% of samples can be within 10-15% recovery vs reference) | Reported: Supported via internally documented data. The submission states that acceptance criteria apply and are met, but specific data values for this study are not provided in the publicly available summary. It refers to "internally documented data." |
2. Sample Size Used for the Test Set and Data Provenance
- Measuring Range (Integra 800/800 CTS): Not explicitly stated, but the "Measuring Range" section indicates that the extended range for Integra 800/800 CTS is now 0.3 - 3.4 g/dL HbA1c. The previous range was 0.3-2.6 g/dL. No specific sample size for the range extension study is detailed in the provided text.
- Endogenous Interferences: The criteria implicitly suggest testing with relevant concentrations of interfering substances. No specific sample size per interferent is mentioned.
- Anticoagulant (Potassium fluoride/Na2-EDTA): "Testing of ≥ 50 paired samples (i.e. serum/plasma)". The provenance of this data is "internally documented data," suggesting it was generated by Roche Diagnostics, likely in-house. It is prospective data collection for this specific evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This device measures a biochemical analyte (HbA1c). The "ground truth" or reference values are established through certified reference methods or calibrated devices. There are no "experts" in the human diagnostic image review sense to establish ground truth for a clinical chemistry assay like HbA1c. The assessment is based on comparison to an established reference method or predicate device performance. The text mentions "Based on study done with IFCC standardization" for expected values.
4. Adjudication Method
Not applicable. This is a quantitative chemical assay, not a subjective interpretation task requiring expert adjudication of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not a diagnostic imaging or interpretive device that relies on human readers. Its performance is measured quantitatively against reference values.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Yes, the studies described are standalone performance evaluations of the assay system itself. For example, the precision, lower detection limit, endogenous interferences, and anticoagulant validation are all tests of the device's inherent analytical performance, independent of human interpretation.
7. Type of Ground Truth Used
- Measuring Range: Established by the ability of the assay to accurately quantify HbA1c within that range, likely by measuring samples with known HbA1c concentrations (e.g., control materials, spiked samples) traceable to a reference method (like IFCC).
- Endogenous Interferences: Established by comparing measurements of samples containing known concentrations of HbA1c with and without the interfering substance, using a reference method if necessary, or comparing to the predicate's performance.
- Anticoagulant: Ground truth for this would be the HbA1c values obtained from samples collected with the originally accepted anticoagulants or a reference method, against which samples collected with the new anticoagulant (potassium fluoride/Na2-EDTA) are compared. The reference values are NGSP values (National Glycohemoglobin Standardization Program), indicating traceability to a globally accepted standardization system for HbA1c.
8. Sample Size for the Training Set
Not applicable. This is a laboratory diagnostic assay, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" of such a system involves the development of reagents and optimization of the assay protocol by Roche Diagnostics.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of machine learning. The assay's analytical performance (linearity, accuracy, precision) is established through validation studies using reference materials and patient samples with known values. The expected values for HbA1c are based on "IFCC standardization," which provides a robust, internationally recognized reference system.
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