(71 days)
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
Through this submission, it is the intention of Roche to gain clearance of an additional 4 COBAS Reagent Cassettes and 6 ancillary reagents. These are the COBAS INTEGRA Cassette for Antithrombin III, COBAS INTEGRA Cassette for Ferritin, COBAS INTEGRA Cassette for Myoglobin, COBAS INTEGRA Cassette for Rheumatoid Factors, Roche Plasmachrom Calibrator, Roche Plasmachrom N & P Controls, Roche FERR T Standard, Roche FERR/MYO T Control, Roche MYOT Standard, and Roche RF Standard II. The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYOT Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Calcium. The performance of the COBAS INTEGRA Reagent Cassette for Calcium has been improved due to the use of new instrument parameters.
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
The provided text describes several COBAS INTEGRA Reagent Cassettes and ancillary reagents. Each product has its own performance characteristics detailed in separate tables comparing it to a predicate device. I will break down the acceptance criteria and study information for each of the primary assay cassettes.
General Information Applicable to All Devices:
- Data Provenance: Not explicitly stated, but clinical and non-clinical studies are mentioned. It is implicitly retrospective as it compares performance to predicate devices and existing methodologies.
- Number of experts used to establish ground truth & qualifications: Not specified.
- Adjudication method: Not specified.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as these are diagnostic assays, not image-based AI systems involving human readers.
- Standalone (algorithm only) performance: This is the core of the evaluation for these devices, as they are automated diagnostic assays.
- Type of ground truth: For accuracy, the ground truth is established by correlation to a legally marketed predicate device or a clinical method (e.g., enzyme immunoassay, radioimmunoassay).
1. COBAS INTEGRA Cassette for Antithrombin III
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Berichrom AT III) | Reported Device Performance (COBAS INTEGRA AT III) |
|---|---|---|
| Assay Range | 0-140% | 0-150% |
| Precision (Day-to-day) | Normal plasma: 1.0-2.5% | 4.1% at 51.9% |
| Pathological plasma: 1.5-3.0% | 2.8% at 105.7% | |
| Accuracy (R-value) | > 0.95 vs. Berichrom Reagent | R = 0.973 vs. Berichrom Reagent |
| Sensitivity (Analytical) | Not specified in labeling | 1.6 X 10⁻³ ΔA/min per % change in AT III activity |
Study Details:
- Sample size for test set: N = 200 (for Accuracy)
- Sample size for training set: Not specified.
- How ground truth for training set was established: Not specified.
2. COBAS INTEGRA Cassette for Ferritin
Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria (Predicate: Behring N Latex Ferritin) | Reported Device Performance (COBAS INTEGRA Ferritin) |
|---|---|---|
| Assay Range | 5-320 ug/L | 0-300 ug/L (0-3000 ug/L with postdilution) |
| Precision (Within-run) | 3.8% at 5 ug/L | |
| 1.5% at 15 ug/L | 9.9 % at 19 ug/L | |
| 1.2 % at 260 ug/L | ||
| Accuracy (Regression) | y = 0.80x + 2.9 ug/L vs.behring N Latex Ferritin; |
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.