(23 days)
CREA reagent, when used in conjunction with UniCel® DxC 600/800 System(s), SYNCHRON® Systems Multi Calibrator and the CRTX Application Sheet, is intended for the quantitative determination of Creatinine concentration in human serum or plasma as a User Defined Reagent (UDR) application.
Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.
The SYNCHRON Systems Creatinine (CREA) reagent is designed for optimal performance on SYNCHRON CX and UniCel DxC SYNCHRON instrument models. The reagent kit contains two 300-test cartridges that are packaged separately from the associated calibrator.
The candidate CRTX User Defined application is designed for optimal use on UniCel DxC Systems as a sample-blanked method to reduce bilirubin interference in serum and plasma samples.
The provided text describes a 510(k) premarket notification for a modification to the SYNCHRON Systems Creatinine Reagent. This submission mainly focuses on the intended use, device description, and a comparison to the predicate device, emphasizing the reduction of bilirubin interference.
However, the document does not contain the specifics needed to completely fill out the acceptance criteria and study details as requested in the prompt. It states "Performance data from verification testing supports equivalency" but does not elaborate on the details of this testing.
Therefore, many sections of your request cannot be fully answered from the provided text. I will fill in what information is available and indicate where information is missing.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission states "Performance data from verification testing supports equivalency," but does not list specific acceptance criteria or quantitative performance results (e.g., accuracy, precision, linearity, interference studies with specific values).
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not provided.
- Data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This device is a reagent for diagnostic testing (Creatinine concentration). The "ground truth" for chemical assays like this is typically established through reference methods, certified standards, and analytical validation (e.g., comparison to a predicate, linearity studies). The concept of "experts" in the context of image interpretation (like radiologists) does not directly apply here. Therefore, this information is not relevant in the same manner as for AI-driven image analysis devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for this type of in vitro diagnostic device focused on chemical assay performance. Adjudication methods are typically used in studies involving human interpretation, often in imaging or clinical decision scenarios.
5. 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:
- No, an MRMC study was not done/is not applicable. This device is an in vitro diagnostic reagent, not an AI-driven interpretation tool intended to assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- As an in vitro diagnostic reagent, the device itself provides a quantitative measurement. The "standalone" performance, in this context, refers to its analytical performance characteristics (accuracy, precision, linearity, interference, etc.). The document indicates "Performance data from verification testing supports equivalency" but does not provide the specific results of these standalone performance metrics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For a chemical assay, the "ground truth" would be established using reference methods or certified reference materials to determine the true concentration of creatinine in samples. The document does not explicitly state the methodology used to establish the ground truth for their verification testing, but this is the standard approach for such devices.
8. The sample size for the training set:
- Not applicable/Not provided. This is a chemical reagent, not a machine learning algorithm that requires a "training set" in the conventional sense of AI development.
9. How the ground truth for the training set was established:
- Not applicable/Not provided for the same reasons as #8.
§ 862.1225 Creatinine test system.
(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.