(34 days)
MCC™ URICHECK™ from HEMATRONIX, INC. is a synthetic matrix based assayed liquid urine multi-constituent control intended to monitor the precision and accuracy of instrument used in the clinical laboratory environment. MCC™ URICHECK™ is intended to monitor the precision and accuracy of instrument used in the methods when run as a patient sample and is ready to use. Expected ranges for the chemical and physical properties of MCC™ URICHECK™ have been established for monitoring or quantitative "constituents" used in routine clinical chemistry analysis.
MCC™ URICHECK™ Assayed Liquid Urine Multi-Constituent Control is a synthetic matrix based assayed liquid urine multi-constituent control.
This document pertains to a 510(k) premarket notification for a medical device called the "MCC™ URICHECK™ Assayed Liquid Urine Multi-constituent Control." It is a regulatory letter from the FDA, and as such, it does not contain the acceptance criteria or a study proving the device meets those criteria.
The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device has been cleared based on demonstrating substantial equivalence to a predicate device, rather than through a new clinical effectiveness study demonstrating specific performance against acceptance criteria.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth details from this document.
The document only provides:
- Device Name: MCC™ URICHECK™ Assayed Liquid Urine Multi-constituent Control
- Intended Use: To monitor the precision and accuracy of instruments used in methods for chemistry analysis in a clinical laboratory environment by being run as a patient sample.
§ 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.