(650 days)
The Randox Laboratories Ltd. Methamphetamine Assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of Methamphetamine in numan urine at the cut off of 1000ng/ml. The assay is calibrated against methamphetamine. Qualitative and semi-quantitative results can be utilized in the diagnosis and treatment of Methamine use or overdose. The Randox Methamphetamine Assay has been developed for use on the form analysers, which includes the And the annound " and the annound" This in vitro diagnostic device is intended for prescription use only.
The semi-quantitative mode is for purposes of
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(1) enabling laboratories to determine an appropriate dilution of the specimen for confirmation by a confirmatory method such as GCMS
or -
(2) permitting laboratories to establish quality control procedures.
This assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatograph/Mass Spectrometry(GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.
The Randox Multidrug Calibrator Set consists of liquid calibrators containing Methamphetamine, Oxazepam and Methadone. There are 5 levels of calibrator. They have been developed for use in the calibration of Methamphetamine, Benzodiazepines and Methadone assays for use on the Drawn analysers, which includes the _________________________________________________________________________________________________________________________________________________________________ use only.
The Randox Multidrug Controls level 1 and 2 are liquid controls containing Methamphetamine. Oxazepam and Methadone. There are 2 levels of controls. They have been developed for use in the quality control of Methamphetamine, Benzodiazepines and Methadone assays for use on the Oxecure analysers, which includes the JX day to na™ and the forman". This in vitro diagnostic device is intended for prescription use only.
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This document describes K092266, a 510(k) premarket notification for the Randox Methamphetamine Assay, Randox Multidrug Calibrator Set, and Randox Multidrug Controls, Level 1 & 2. However, the provided text does not contain the acceptance criteria or the study data that proves the device meets specific acceptance criteria.
The document primarily focuses on the FDA's clearance of the device as substantially equivalent to legally marketed predicate devices, and outlines the "Indications for Use" for each component of the Randox product suite. It also mentions general regulatory requirements.
Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them based on the provided text.
To answer your request, I would need a different section of the 510(k) submission, likely a performance study summary or a section detailing verification and validation activities.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). 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.