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K Number
K974234
Device Name
MICRO-PLATE COTININE EIA
Manufacturer
ORASURE TECHNOLOGIES, INC.
Date Cleared
1998-05-14

(183 days)

Product Code
MKU
Regulation Number
862.3220
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter for the "STC Cotinine Micro-Plate EIA" device. It does not contain the detailed study information required to answer all parts of your request. Specifically, it lacks:

  • A table of acceptance criteria and reported device performance.
  • Details on sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods for test and training sets.
  • Information on MRMC studies or standalone algorithm performance.

The document primarily focuses on:

  • The FDA's determination of substantial equivalence for the device (K974234).
  • The regulatory classification (Class II, Product Code MKU).
  • General controls and applicable regulations.
  • The intended use of the device.

Therefore, I cannot provide a complete answer to your request based solely on the provided text. I can, however, extract the Indications for Use as this is the only performance-related information explicitly stated:

Indications For Use: The STC Cotinine Micro-Plate EIA is intended for use in the qualitative and semi-quantitative determination of cotinine in oral fluid collected with the EpiScreen™ Oral Specimen Collection Device. For In Vitro Diagnostic Use.

To answer your request thoroughly, I would need access to the actual 510(k) submission document (K974234) which details the validation studies conducted for the device.

§ 862.3220 Carbon monoxide test system.

(a)
Identification. A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.(b)
Classification. Class I (general 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.