(50 days)
CLINITEK Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for small amounts of albumin in urine (microalbuminuria) creatinine) in urine, and also determine the albumin-to-creatinine ratio in urine. The strips are read instrumentally using the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer and provide semi-quantitative results. CLINITEK Microalbumin Reagent Strips can be used for screening urine specimens for microalbuminuria as an aid in the detection of patients at risk for developing kidney damage. CLINITEK Microalbumin Reagent Strips are for professional use.
CLINITEK® Microalbumin Reagent Strips are firm plastic strips that contain two reagent areas to test for microalbumin (low concentration of albumin) and creatinine in urine. CLINITEK Microalbumin Reagent Strips are dipped into a urine specimen and "read" instrumentally by the CLINITEK® 50 or CLINITEK® 100 Urine Chemistry Analyzer. In addition to providing an albumin and a creatinine result, an albumin-to-creatinine ratio is also determined. Semi-quantitative results are available within one minute.
The provided document describes the CLINITEK® Microalbumin Reagent Strips, which screen urine for microalbuminuria and creatinine. The device is intended for professional use in point-of-care settings.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the acceptance criterion was demonstrating "substantial equivalence to current methods" for microalbumin and creatinine in urine. It reports that the device's performance meets this criterion.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to current methods. | Studies demonstrated that typical users in decentralized, point-of-care laboratories can obtain clinical test results that are substantially equivalent to current methods. |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "clinical settings by typical users of the system" but does not specify the sample size for the test set.
The provenance of the data is implied to be prospective as it involved studies "in clinical settings by typical users," suggesting real-world testing. The country of origin for the data is not explicitly stated, but the submitter is based in Elkhart, IN, USA, which might imply the studies were conducted within the US.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not provide information on the number of experts or their qualifications used to establish ground truth. It states that results were "compared to currently used tests for microalbumin and creatinine in urine," implying that the "ground truth" was established by these existing, well-accepted tests rather than independent expert consensus.
4. Adjudication Method for the Test Set:
The document does not specify an adjudication method. It notes that the device's results were "compared to currently used tests," suggesting a direct comparison rather than a multi-reader adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as described in the document. The study focuses on the device's performance compared to existing methods, not on how human readers' performance with or without AI assistance changes.
6. Standalone Performance Study:
Yes, a standalone performance study was done. The assessment of performance states, "The performance of CLINITEK® Microalbumin Reagent Strips was studied in clinical settings by typical users of the system and results compared to currently used tests for microalbumin and creatinine in urine." This indicates that the algorithm's (the reagent strip and analyzer system) performance was evaluated independently against established methods.
7. Type of Ground Truth Used:
The ground truth used was established by comparison to currently used, established tests for microalbumin and creatinine in urine. This can be considered a form of reference standard data, where the performance of the new device is benchmarked against existing, validated laboratory methods.
8. Sample Size for the Training Set:
The document does not provide information on the sample size used for any training set. Given that this is a 510(k) submission for a reagent strip device, the "training set" concept (as it relates to machine learning algorithms) may not be directly applicable in the same way it would for an AI-powered diagnostic. The device functions based on chemical reactions and instrumental readings, which are inherently "trained" by the design and calibration of the chemical reagents and the optical reader, rather than a data-driven machine learning training set.
9. How Ground Truth for the Training Set Was Established:
As mentioned above, the concept of a "training set" with ground truth in the current AI/ML sense is not applicable here. The "training" for such a device would involve extensive laboratory development and characterization of the chemical reactions and the instrument's calibration and reading algorithms against known concentrations of analytes. The document does not detail how this foundational characterization or "training" (in a non-ML sense) was established.
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.