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K Number
K012582
Device Name
AMEDITECH IMMUTEST DRUG SCREEN PCP
Manufacturer
AMEDITECH, INC.
Date Cleared
2001-11-30

(112 days)

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

The Ameditech ImmuTest™ Drug Screen PCP is an In Vitro screen test for the qualitative detection of Phencyclidine in human urine at cut-off concentration of 25 ng/ml. This test kit is used to obtain a visual, qualitative result and is intended for professional use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information needed to describe the acceptance criteria and the study that proves the device meets them in the format requested. The document is an FDA 510(k) clearance letter for the Ameditech ImmuTest™ Drug Screen PCP, stating that the device is substantially equivalent to legally marketed predicate devices.

Specifically, the document does not include:

  • A table of acceptance criteria and reported device performance.
  • Sample sizes for test or training sets.
  • Data provenance.
  • Number or qualifications of experts.
  • Adjudication methods.
  • Information on MRMC comparative effectiveness studies or standalone performance studies.
  • Details on how ground truth was established for either test or training sets.

The relevant information in the provided document is limited to:

  • Device Name: Ameditech ImmuTest™ Drug Screen PCP
  • Regulatory Number: Unclassified
  • Product Code: LCM
  • Indications For Use: An In Vitro screen test for the qualitative detection of Phencyclidine in human urine at a cut-off concentration of 25 ng/ml. Intended for professional use to obtain a visual, qualitative result.

To provide the comprehensive answer you're looking for, I would need a different type of document, such as a summary of safety and effectiveness data (SSED), a clinical study report, or the full 510(k) submission, which would detail the performance data and testing methodologies.

N/A