(204 days)
The EasyRA PPX reagent is intended for the qualitative and semi-quantitative measurement of Propoxyphene (PPX) in human urine, using MEDICA's EasyRA Chemistry Analyzer in clinical laboratories. The cut-off point of the assay is 300ng/ml, and provides only a preliminary analytical result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS) are the preferred confirmatory method. The semi-quantitative mode is intended to enable laboratories to determine the appropriate dilution of the specimen for confirmation by a reference method such as GC/MS or LC/MS and to allow laboratories to establish effective quality control procedures for the PPX assay.
Medica's Propoxyphene (PPX) Calibrators are intended for the calibration of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent on the EasyRA clinical chemistry analyzer.
Medica's Propoxyphene (PPX) QC Materials are intended for the validation of the PPX Enzymatic Immunoassay to estimate propoxyphene in human urine, using Medica's PPX reagent and PPX calibrator on the EasyRA clinical chemistry analyzer.
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This document is a 510(k) premarket notification decision letter from the FDA for in vitro diagnostic devices (IVDs) related to Propoxyphene (PPX) testing. It does not contain information about acceptance criteria or a study proving device performance as requested.
The document states that the FDA has reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices. This means the device's performance is considered similar enough to existing devices, and a separate study demonstrating new acceptance criteria or performance against such criteria is not typically required in a 510(k) for substantial equivalence.
Therefore, I cannot provide the requested information from the given text because it is not present.
§ 862.3700 Propoxyphene test system.
(a)
Identification. A propoxyphene test system is a device intended to measure propoxyphene, a pain-relieving drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of propoxyphene use or overdose or in monitoring levels of propoxyphene to ensure appropriate therapy.(b)
Classification. Class II (special controls). A propoxyphene test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (e.g., programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).