(63 days)
The CLINITEK ATLAS PRO 12 Reagent Pak system is intended for use in at-risk patient groups to assist diagnosis in the following areas: kidney function, carbohydrate metabolism, urinary tract infections and liver function. The system also measures physical characteristics, including acid-base balance and urine concentration. Test results can be used along with other diagnostic information to rule out certain disease states. The CLINITEK ATLAS PRO Reagent Pak system is for professional use in centralized laboratory locations such as in hospitals and reference laboratories.
The CLINITEK ATLAS PRO 12 Reagent Pak is a roll of firm plastic to which are affixed 490 reagent strips. It is for use with the CLINITEK ATLAS® Automated Urine Chemistry Analyzer. Each reagent strip contains 11 separate reagent areas to test for low level protein (15 mg/dL albumin), high level protein (>30 mg/dL protein), creatinine, occult blood, glucose, ketone (acetoacetic acid), leukocytes, nitrite, pH, bilirubin and urobilinogen. A protein-to-creatinine ratio is also determined. In addition, each strip contains a nonreactive 12th pad that is used for the determination of the specimen color.
The provided text describes a 510(k) submission for the CLINITEK ATLAS PRO 12 Reagent Pak System. However, it does not include specific quantitative acceptance criteria or detailed results of a study designed to prove the device meets such criteria.
The document generally states: "The performance of the CLINITEK ATLAS PRO 12 Reagent Pak System was studied internally and in clinical settings. The studies demonstrated that typical users in centralized laboratories could obtain clinical test results that are comparable to commonly used laboratory tests." And, "Studies show that the product provides clinical results comparable to other test methods in current clinical practice."
Without specific acceptance criteria and an actual study report with raw data or summary statistics, it's impossible to completely fill out the requested table and answer many of the study-specific questions.
Here's an attempt to answer based only on the provided text, highlighting what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The provided text does not specify quantitative acceptance criteria for the CLINITEK ATLAS PRO 12 Reagent Pak System. It only makes a general statement about performance being "comparable to commonly used laboratory tests." Therefore, the "Acceptance Criteria" column cannot be filled with specific numbers or thresholds. The "Reported Device Performance" is also broad.
| Performance Metric (for Creatinine and Low Level Protein/Albumin Detection, and Protein-to-Creatinine Ratio) | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Creatinine Test Accuracy/Comparability | Not specified | Comparable to commonly used laboratory tests |
| Low Level Protein (Albumin at 15 mg/dL) Test Accuracy/Comparability | Not specified | Comparable to commonly used laboratory tests |
| Protein-to-Creatinine Ratio Accuracy/Comparability | Not specified | Comparable to commonly used laboratory tests |
| Other analytes (Occult blood, glucose, ketone, leukocytes, nitrite, pH, bilirubin, urobilinogen, high level protein) | Not specified | Comparable to commonly used laboratory tests |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified.
- Data Provenance: "studied internally and in clinical settings." This implies a mix, but specific countries or retrospective/prospective nature are not described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document refers to "commonly used laboratory tests" as the comparison, implying these tests served as a reference standard, but the process of establishing ground truth for individual samples using experts is not detailed.
4. Adjudication method for the test set
- Not specified.
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. This device is an automated urine chemistry analyzer system, not an AI-assisted diagnostic imaging or interpretation tool for human readers. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, effectively. The "device" in this context (CLINITEK ATLAS PRO 12 Reagent Pak System used with the CLINITEK ATLAS® Automated Urine Chemistry Analyzer) operates as an automated system. The performance assessment describes its results as comparable to other laboratory methods. This fits the description of a "standalone" or "algorithm only" performance, as the system itself produces the results without direct human interpretive input being evaluated. The document states "typical users in centralized laboratories could obtain clinical test results," suggesting the system's output is directly used.
7. The type of ground truth used
- The ground truth was established by "commonly used laboratory tests" or "other test methods in current clinical practice." This implies comparison to existing, validated diagnostic methods. Specifics of these methods (e.g., gold standard chemical assays for creatinine, micro-albuminuria tests for low-level protein) are not detailed.
8. The sample size for the training set
- Not applicable as this is not a machine learning/AI model described to be "trained." This is a diagnostic reagent system.
9. How the ground truth for the training set was established
- Not applicable (see point 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.