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K Number
K982801
Device Name
AUTO-LYTE PCP EIA, MODEL #1254U
Manufacturer
ORASURE TECHNOLOGIES, INC.
Date Cleared
1998-11-04

(86 days)

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

The STC AUTO-LYTE® PCP EIA is intended for use in the qualitative determination of phencyclidine in urine. This test is intended for in vitro diagnostic use.

Device Description

Not Found

AI/ML Overview

I am sorry. This document does not contain the information you are looking for. This document is a letter from the FDA to STC Technologies, Inc. regarding the 510(k) premarket notification for their AUTO-LYTE® PCP EIA (Urine) device. It confirms the device's substantial equivalence to legally marketed predicate devices and outlines the regulatory requirements. It does not provide details on acceptance criteria, study designs, sample sizes, or expert qualifications related to the device's performance.

N/A