(46 days)
CardioQuant™ Cardiac Assessment Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of clinical diagnostic test methods for troponin I, CK-MB and myoglobin. These external controls compliment the monitoring of the test performance by the kit specific controls provided by each test device manufacturer.
Not Found
This is a New 510(k) K991447 for a Class I device, CardioQuant™ Cardiac Assessment Controls. As such, there is no discussion of acceptance criteria, device performance, or study design. There would have been no requirement for clinical studies to prove substantial equivalence. All the information that can be extracted is described below.
1. A table of acceptance criteria and the reported device performance
Not applicable for this device and 510(k) submission.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable for this device and 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable for this device and 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this device and 510(k) submission.
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 for this device and 510(k) submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable for this device and 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for this device and 510(k) submission.
8. The sample size for the training set
Not applicable for this device and 510(k) submission.
9. How the ground truth for the training set was established
Not applicable for this device and 510(k) submission.
§ 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.