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K Number
K983127
Device Name
OPIATES 2000 LIQUID OPIATES DRUGS OF ABUSE CONTROL LEVELS G2 AND G3
Manufacturer
MEDICAL ANALYSIS SYSTEMS, INC.
Date Cleared
1998-09-14

(6 days)

Product Code
DIF
Regulation Number
862.3280
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3 are intended for use as a consistent tool for monitoring assay performance of patient urine specimens. Include the controls with patient urine specimens when assaying for opiates.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text only contains a cover letter from the FDA regarding a 510(k) premarket notification for "Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels 1 and 2". It also includes a "Statement of Indications for Use" for "Opiates 2000 GC/MS Liquid Opiates Drugs of Abuse Control Levels G2 and G3".

This document does not contain any information about:

  1. Acceptance criteria or reported device performance.
  2. Sample sizes for test sets or data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. Multi-reader multi-case (MRMC) comparative effectiveness study.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth was established for the training set.

Therefore, I cannot fulfill your request with the input provided.

§ 862.3280 Clinical toxicology control material.

(a)
Identification. A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.(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.