(13 days)
Biokit's ASO-CRP-RF control 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 contains a known assayed value of antistreptolysin-O, C-reactive protein and rheumatoid factor, is mixed with the quantex ASO plus, quantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
Biokit's ASO-CRP-RF control 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 contains a known assayed value of antistreptolysin-O, C-reactive protein and rheumatoid factor, is mixed with the quantex ASO plus, quantex CRP plus, or quantex RF plus latex reagent, a clear agglutination occurs which can be measured by turbidimetry.
The provided document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "quantex ASO-CRP-RF control."
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating "substantial equivalence" in performance to predicate devices, specifically in terms of within-run variance (%CV). While explicit numerical acceptance criteria values are not stated as "acceptance criteria," the reported performance demonstrates similarity to the predicate devices, which is the basis for substantial equivalence.
| Analyte | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (quantex ASO-CRP-RF control) | Predicate Device Performance |
|---|---|---|---|
| ASO | Statistically similar within-run %CV to quantex ASO plus control | 2.8% | 1.9% (quantex ASO plus) |
| CRP | Statistically similar within-run %CV to quantex CRP plus control | 3.3% | 2.6% (quantex CRP plus) |
| RF | Statistically similar within-run %CV to quantex RF plus control | 1.8% | 1.7% (quantex RF plus) |
| Note: The acceptance criteria are implicitly defined by the performance of the predicate devices. The study aimed to show "statistically similar" performance. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific number of runs or observations (sample size) used for the comparative performance study on the COBAS Mira. It only reports the calculated %CV values.
- Data Provenance: The document does not specify the country of origin of the data. The study appears to be a prospective performance study conducted by Biokit, comparing their new combined control to existing individual controls.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this submission. The device is a quality control material for in vitro diagnostics. The "ground truth" for its performance is determined by its analytical characteristics (e.g., precision, accuracy) when measured on an instrument, not by expert interpretation of clinical data.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes, not for the analytical performance evaluation of a quality control material.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for devices that involve human interpretation (e.g., imaging devices) and aims to assess the impact of AI on reader performance. The "quantex ASO-CRP-RF control" is an in vitro diagnostic quality control material, not subject to MRMC studies.
- Effect Size of Human Reader Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone study was done. The performance study described (comparative performance study on a COBAS Mira) evaluates the performance of the "quantex ASO-CRP-RF control" itself, as a quality control material, without human interpretation in the workflow of the control's function. The control is used to monitor automated instrumentation.
7. Type of Ground Truth Used
The "ground truth" used for this study is the analytical performance characteristics (specifically, within-run variance expressed as %CV) of the predicate devices. The study aimed to demonstrate that the new device's analytical performance was "statistically similar" to these established predicate devices. The "known assayed value" of the analytes (ASO, CRP, RF) within the control material itself acts as an internal reference for the instrument's measurement.
8. Sample Size for the Training Set
This information is not applicable. The "quantex ASO-CRP-RF control" is a ready-to-use quality control material, not an AI or algorithmic device that requires a training set in the typical machine learning sense. Its composition and manufacturing process define its characteristics.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this device is not an AI/ML algorithm requiring a training set with established ground truth labels.
§ 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.