(50 days)
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents.
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use in the quality control of automated instrumentation to monitor the results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents using the turbidimetric method.
The quantex ASO-CRP-RF control II is an in vitro diagnostic product intended for use with automated instrumentation in monitoring the quality control of results obtained with the quantex ASO plus, quantex CRP plus and quantex RF plus reagents. When the combined control, which ADO prob, qualiten Ord problem of antistreptolysin-O, C-reactive protein and rheumatoid factor, commits a known asserver raias our suantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
The provided document is a 510(k) summary for the quantex ASO-CRP-RF control II device, which is an in vitro diagnostic product. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies to establish new performance criteria. Therefore, several of the requested categories in your prompt are not directly applicable or fully elaborated in this type of regulatory submission.
Here's an analysis based on the information provided:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance (quantex ASO-CRP-RF control II) | Predicate Device Performance (quantex ASO-CRP-RF control) |
|---|---|---|
| Within-run precision (ASO) ≤ predicate %CV | 2.7% %CV | 4.8% %CV |
| Within-run precision (CRP) ≤ predicate %CV | 1.6% %CV | 3.5% %CV |
| Within-run precision (RF) ≤ predicate %CV | 1.1% %CV | 1.7% %CV |
| Substantial equivalence in performance, intended use, and safety and effectiveness to the predicate device. | Deemed substantially equivalent by FDA. | Established as legally marketed. |
Note: The acceptance criteria are implicit as the submission's goal is to demonstrate that the new device is "substantially equivalent" to the predicate. The performance data provided show that the new device's within-run precision (%CV) is better than or equal to the predicate device, thereby meeting the unstated expectation of comparable or improved performance.
2. Sample size used for the test set and the data provenance
- Sample size: Not explicitly stated. The study refers to "a comparative performance study," implying multiple measurements were taken to calculate the %CV, but the exact number of runs or replicates is not specified.
- Data provenance: Not explicitly stated, but typically such studies for regulatory submissions are conducted in a controlled laboratory setting by the manufacturer. It is a retrospective analysis of data generated during the device's development/validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not applicable. The device is a quality control material, not a diagnostic device for which expert consensus on patient conditions would be required. The "ground truth" for a control material is its expected performance characteristics (e.g., precision), which are determined through statistical analysis of its own repeated measurements.
4. Adjudication method for the test set
- Not applicable as explained above.
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
- Not applicable. This device is a quality control material for automated instruments, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- The device itself is a standalone control material. Its performance (precision) was evaluated in a standalone manner on a COBAS Mira instrument. The evaluation did not involve a human-in-the-loop scenario.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in this context is the intrinsic performance characteristics (specifically, within-run precision, expressed as %CV) of the control material itself, and the comparison of these characteristics to those of its predicate device, as measured on the intended automated instrumentation. It's an internal validation of a manufactured product's consistency.
8. The sample size for the training set
- Not applicable. This is a quality control material, not an algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.