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K Number
K972481
Device Name
AUTO-LYTE COTININE EIA
Manufacturer
ORASURE TECHNOLOGIES, INC.
Date Cleared
1997-10-21

(111 days)

Product Code
MKU,DAT
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 Auto-Lyte® Cotinine EIA is a homogeneous immunoassay intended for the qualitative and semiquantitative analysis of cotinine in human urine. Cotinine is the major metabolite of nicotine, and the STC kit is useful in the detection of cotinine after ingestion of or exposure to nicotine. For In Vitro Diagnostic Use.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that you are requesting. The document is an FDA 510(k) clearance letter for the STC Auto-Lyte® Cotinine EIA, indicating that it has been found substantially equivalent to a predicate device.

It specifies:

  • Device Name: STC Auto-Lyte® Cotinine EIA
  • Indications For Use: Homogeneous immunoassay for qualitative and semiquantitative analysis of cotinine in human urine, useful in detecting cotinine after nicotine ingestion or exposure. For In Vitro Diagnostic Use.
  • Regulatory Class: II

However, it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size, data provenance, number of experts, or adjudication method for a test set.
  3. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
  4. Stand-alone algorithm performance.
  5. Type of ground truth used.
  6. Sample size for the training set.
  7. How ground truth for the training set was established.

This document is a regulatory approval, not a performance study report. To find the information you are looking for, you would typically need to refer to the 510(k) submission itself or related study publications if they exist.

§ 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.