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510(k) Data Aggregation
(13 days)
The cassettes COBAS Integra ALP IFCC Gen.2 Small (ALP2S) and COBAS Integra ALP IFCC Gen.2 Large (ALP2L) contain an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.
The COBAS Integra ALP IFCC Gen.2 is a colorimetric assay for the determination of the catalytic activity of alkaline phosphatase in serum or plasma in accordance to the recommended reference method of the International Federation of Clinical Chemists (IFCC). In the presence of magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by phosphatases into phosphate and p-nitro-phenol. The p-nitro-phenol released is directly proportional to the catalytic ALP activity.
This is an in vitro diagnostic device for quantitative determination, not an AI/ML device. The request asks for details specific to AI/ML device studies that are not applicable here. However, I can still extract the acceptance criteria and the summary of the study proving the device meets them based on the provided text, focusing on performance characteristics relevant to an IVD.
Here's the summary:
1. Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Performance Characteristic | Reported Device Performance (COBAS Integra ALP IFCC Gen.2) |
|---|---|
| Intended Use | Quantitative determination of catalytic activity of alkaline phosphatase in human serum and plasma for diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. |
| Method | Colorimetric assay in accordance with the recommended reference method of the International Federation of Clinical Chemistry (IFCC). |
| Sample Type | Serum, Heparin plasma |
| Measuring Range | 2 - 1200 U/L |
| Expected Values (at 37° C) | Adults: Females: 35 - 104 U/L, Males: 40 - 129 U/L Children: 1 day: < 250 U/L, 2 - 5 days: < 231 U/L, 6 days - 6 months: < 449 U/L, 7 months - 1 year: < 462 U/L, 1 - 3 years: < 281 U/L, 4 - 6 years: < 269 U/L, 7 - 12 years: < 300 U/L, 13 - 17 years (f): < 187 U/L, 13 - 17 years (m): < 390 U/L |
| Substantial Equivalence | Claims substantial equivalence to the currently marketed COBAS Integra ALP IFCC Assay (K981897). |
2. Study that Proves the Device Meets Acceptance Criteria:
The provided document is a 510(k) Summary for a COBAS Integra ALP IFCC Gen.2, an in vitro diagnostic reagent system. The primary method described for demonstrating its meeting of acceptance criteria is a comparison to a legally marketed predicate device to establish substantial equivalence.
- Study Type: This is a comparative study against an existing, cleared device (the predicate device: COBAS Integra ALP IFCC Assay, K981897). The intent is to show that the new device performs similarly and is safe and effective as the predicate.
- Data Provenance and Sample Size: The document does not explicitly state the sample size used for the comparison or the data provenance (e.g., country of origin, retrospective/prospective). For an IVD, comparison studies typically involve patient samples and/or control materials.
- Ground Truth Establishment: The ground truth for such quantitative assays is usually established by a reference method or a calibrated reference material. The document states that the assay is a "colorimetric assay for the determination of the catalytic activity of alkaline phosphatase in serum or plasma in accordance to the recommended reference method of the International Federation of Clinical Chemists (IFCC)." This indicates that the IFCC reference method serves as the ground truth or the standard against which the device's performance is measured.
3. AI/ML Specific Questions (Not Applicable to this Device):
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This is a biochemical assay, not an imaging device requiring expert interpretation. The ground truth is based on a reference standard/method (IFCC).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically for evaluating subjective interpretations, which is not the case for a quantitative biochemical assay.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI-assisted diagnostic tool that involves human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a reagent and instrument system, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth is based on the recommended reference method of the International Federation of Clinical Chemists (IFCC) for alkaline phosphatase activity. This would involve specific chemical reactions and measurements rather than expert consensus on subjective findings.
- The sample size for the training set: Not applicable. This is not an AI/ML device that requires training data in the conventional sense. Device development would involve optimization and calibration using various samples, but not a "training set" like an AI model.
- How the ground truth for the training set was established: Not applicable for the same reason given above. The device's performance is calibrated and validated against established reference methods for the analyte.
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