(82 days)
The cassette COBAS INTEGRA x-1-Antitrypsin (AAT) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human x-1-antitrypsin in serum and plasma. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, a-1-antitrypsin deficiency has been associated with pulmonary emphysema.
The cassette COBAS INTEGRA Immunoglobulin A (IGA/IGAP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin A in serum and plasma. addition to the standard application (IGA), the sensitive application (IGAP) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cassette COBAS INTEGRA Immunoglobulin M (IGM/IGMP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin M in serum and plasma. In addition to the standard application (IGM), the sensitive application (IGMP) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cassette COBAS INTEGRA Immunoglobulin G (Turbidimetric) (IGGT/IGGTC) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin G in serum, plasma (IGGT) and cerebrospinal fluid (IGGTC). Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer, which is also known as the COBAS INTEGRA 700. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
Here's a breakdown of the acceptance criteria and study information for the Roche COBAS® INTEGRA Reagent Cassettes for α-1-Antitrypsin (AAT), Immunoglobulin A (IGA/IGAP), and Immunoglobulin M (IGM/IGMP), based on the provided text:
Important Note: The provided document is a 510(k) Summary. This type of summary focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific pre-defined acceptance criteria in the same way a novel device might. The "acceptance criteria" here are inferred from the performance characteristics presented to show equivalence. The studies are primarily comparative studies against predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Roche COBAS® INTEGRA Reagent Cassettes (AAT, IGA/IGAP, IGM/IGMP)
| Performance Characteristic | Acceptance Criteria (inferred from predicate/previous version) | Reported Device Performance (Modified COBAS INTEGRA) | Predicate Device Performance (where available) |
|---|---|---|---|
| α-1-Antitrypsin (AAT) | |||
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., K972640: 0.967 / K954992: 0.930) | 0.995 (vs. BM) | Predicate K972640: 0.967; Cleared K954992: 0.930 |
| Linear Regression | Must be comparable to predicate | 1.30x - 0.31 g/L | Predicate K972640: 0.993x + 9.9 mg/dL; Cleared K954992: 0.90x + 0.06 g/L |
| Immunoglobulin A (IGA/IGAP) | |||
| Precision (IGA) | |||
| Level 1 (Mean ~2.0-2.3 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.9%, Cleared: 1.4%) | 2.0% | Predicate BM: 0.9%; Cleared K954457: 1.4% |
| Level 2 (Mean ~3.5-6.2 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.8%, Cleared: 0.81%) | 0.97% | Predicate BM: 0.8%; Cleared K954457: 0.81% |
| Total CV Level 1 | Total CV comparable to predicate/cleared (e.g., BM: 2.2%, Cleared: 2.8%) | 2.3% | Predicate BM: 2.2%; Cleared K954457: 2.8% |
| Total CV Level 2 | Total CV comparable to predicate/cleared (e.g., BM: 1.8%, Cleared: 1.8%) | 1.2% | Predicate BM: 1.8%; Cleared K954457: 1.8% |
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., BM: 0.99 / Cleared: 0.989) | 0.994 (vs. BM/Hitachi) | Predicate BM: 0.99; Cleared K954457: 0.989 |
| Linear Regression | Must be comparable to predicate | 1.023x - 0.214 g/L | Predicate BM: 0.83x + 20.6 mg/dL; Cleared K954457: 0.97x - 0.05 g/L |
| Assay Range | Must be comparable or improved | 0.45 - 7.3 g/L (std); 0.15 - 98.6 g/L (rerun) | Cleared K954457: 0.79 - 12.6 g/L (std); 0.27 - 30.2 g/L (rerun) |
| Sensitivity | Must be comparable or improved | 0.45 g/L | Cleared K954457: 0.79 g/L |
| Immunoglobulin M (IGM/IGMP) | |||
| Precision (IGM) | |||
| Level 1 (Mean ~0.55-0.6 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.79%, Cleared: 2.6%) | 2.4% | Predicate BM: 0.79%; Cleared K954457: 2.6% |
| Level 2 (Mean ~1.9-2.0 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.8%, Cleared: 2.0%) | 1.6% | Predicate BM: 0.8%; Cleared K954457: 2.0% |
| Total CV Level 1 | Total CV comparable to predicate/cleared (e.g., BM: 3.7%, Cleared: 3.1%) | 3.2% | Predicate BM: 3.7%; Cleared K954457: 3.1% |
| Total CV Level 2 | Total CV comparable to predicate/cleared (e.g., BM: 2.4%, Cleared: 2.2%) | 1.9% | Predicate BM: 2.4%; Cleared K954457: 2.2% |
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., BM: 0.979 / Cleared: 0.994) | 0.994 (vs. BM/Hitachi) | Predicate BM: 0.979; Cleared K954457: 0.994 |
| Linear Regression | Must be comparable to predicate | 1.293x + 0.341 g/L | Predicate BM: 0.81x + 5.9 mg/dL; Cleared K954457: 1.12x - 0.06 g/L |
| Assay Range | Must be comparable or improved | 0.16 - 5.18 g/L (std); 0.05 - 24.35 g/L (rerun) | Cleared K954457: 0.31 - 5.0 g/L (std); 0.11 - 12.1 g/L (rerun) |
| Sensitivity | Must be comparable or improved | 0.16 g/L | Cleared K954457: 0.31 g/L |
2. Sample Sizes Used for the Test Set and Data Provenance
- α-1-Antitrypsin (AAT):
- Sample Size: 288
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
- Immunoglobulin A (IGA/IGAP):
- Sample Size: 584
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
- Immunoglobulin M (IGM/IGMP):
- Sample Size: 556
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic reagent, and the 'ground truth' is established by comparative measurements against predicate devices using laboratory methods, not human expert interpretation of images or clinical cases. The comparison is against established laboratory testing methods.
4. Adjudication Method for the Test Set
Not applicable. The 'test set' here consists of biological samples measured by the device and compared to results from predicate devices/methods. There is no human adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are typically for imaging devices or AI tools that assist human readers in interpretation. This is an IVD reagent, and the effectiveness is evaluated through analytical performance characteristics like accuracy, precision, and linearity when compared to established methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The studies summarized are standalone performance evaluations of the reagent cassette on the COBAS INTEGRA Analyzer. The results are generated by the automated system, without "human-in-the-loop" needing to interpret the primary measurement, although human operators load samples and review results. The comparison is between the modified reagent's performance and that of other established laboratory methods (predicate devices).
7. The Type of Ground Truth Used
The ground truth used for these studies is comparative measurement data from legally marketed predicate devices and established laboratory methods. Specifically:
- AAT: Comparison against Boehringer Mannheim α-1-Antitrypsin Reagent (K972640) and Cleared COBAS INTEGRA α-1-Antitrypsin (K954992). The "vs. BM" implies using the Boehringer Mannheim method as a reference.
- IGA/IGAP: Comparison against Boehringer Mannheim Immunoglobulin A Reagent (K955907) and Cleared COBAS INTEGRA Immunoglobulin A (K954457). The "vs. BM/Hitachi" indicates comparison with these laboratory systems.
- IGM/IGMP: Comparison against Boehringer Mannheim Immunoglobulin M Reagent (K955908) and Cleared COBAS INTEGRA Immunoglobulin M (K954457). The "vs. BM/Hitachi" indicates comparison with these laboratory systems.
8. The Sample Size for the Training Set
Not applicable. These are reagent cassettes used with an existing analyzer. There is no mention of machine learning or AI models with "training sets" in the context of this 510(k) submission. The development and optimization of the reagent formulations and assay parameters would be part of a different internal R&D process, not typically described as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device and submission. The "ground truth" for evaluating the performance of these reagents is established through established analytical chemistry and immunology principles, validated against reference materials, and benchmarked against predicate diagnostic assays.
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).