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K Number
K991505
Device Name
MICRO-STRIP FOR PHENCYCLIDINE METABOLITES
Manufacturer
MICRODIAGNOSTICS, INC.
Date Cleared
1999-08-05

(98 days)

Product Code
LCM
Regulation Number
N/A
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is an immunoassay that qualitatively detects the major Phencyclidine metabolites in urine at the SAMHSA cutoff level of 25 ng/m1. The MICRO-STRIP FOR PHENCYCLIDINE METABOLITES is intended for use by clinical toxicology labratories, physician offices, drug abuse clinics and law enforcement agencies only.

Device Description

Not Found

AI/ML Overview

I am unable to answer this question. The provided text is a 510(k) clearance letter from the FDA, which confirms that a device (MICRO-STRIP FOR PHENCYCLIDINE METABOLITES) is substantially equivalent to a legally marketed predicate device.

However, this document does not contain any information about the acceptance criteria, study details, performance data, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for the device. It merely states that the device is cleared for marketing based on its substantial equivalence to a predicate.

Therefore, I cannot extract the requested information from the provided text.

N/A