(13 days)
QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities.
liquid human serum based assayed quality control material
The provided document is a 510(k) clearance letter from the FDA for a medical device called "QUALITROL Cardiac Marker Control, Level 1, 2 and 3". This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed.
However, this document does not contain the detailed information necessary to describe acceptance criteria and a study proving the device meets those criteria. The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, rather than requiring a detailed clinical study demonstrating device performance against specific acceptance criteria.
The letter mentions the "Indications for Use Statement," which describes what the device is intended to do: "QUALITROL CARDIAC MARKER CONTROL, Levels 1, 2 and 3, is a liquid human serum based assayed quality control material intended to monitor the performance of clinical test procedures that analyze for indicators of possible cardiac abnormalities." This statement defines the purpose of the device, but not its performance acceptance criteria.
Therefore, I cannot provide the requested information based solely on the content of this document. A 510(k) submission typically includes data to support substantial equivalence (e.g., analytical performance studies for in-vitro diagnostic devices), but those specific details are not present in this regulatory clearance letter.
To fully answer your request regarding acceptance criteria and a study proving device performance, I would need access to the actual 510(k) submission data (e.g., the analytical studies like precision, accuracy, stability, etc., that would have been submitted to demonstrate the quality control material itself performs as expected).
§ 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.