(10 days)
CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL is intended for use as an assayed quality control material for analysis.
Not Found
The provided document is a 510(k) substantial equivalence determination letter from the FDA for a quality control material (CLINIQA Liquid QC™ Cardiac Marker Controls Levels 1, 2 & 3 Tri-LEVEL). It does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of a diagnostic or therapeutic medical device.
Specifically, the document:
- Identifies the device as a quality control material.
- States its intended use is as an assayed quality control material for analysis.
- Confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices.
This type of FDA clearance pertains to the marketing of a quality control product, not to the performance evaluation of a diagnostic device that might use such controls. Therefore, the information requested in your prompt (Table of acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not present in this document.
§ 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.