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K Number
K981339
Device Name
QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMISTRY CONTROL C3
Manufacturer
CONSOLIDATED TECHNOLOGIES, INC.
Date Cleared
1998-04-21

(8 days)

Product Code
JJY
Regulation Number
862.1660
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

QUICKCHECK CONFORMANCE® Chemistry Control C3 are materials intended for use in monitoring the accuracy and precision of clinical chemistry procedures.

Device Description

QUICKCHECK Lyophilized Chemistry Control Also Distributed as: CONFORMANCE® Chemistry Control C3

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as requested in your prompt. The document is an FDA 510(k) clearance letter for a device called "QUICKCHECK Lyophilized Chemistry Control" (also distributed as "CONFORMANCE® Chemistry Control C3").

This letter primarily states that the device is substantially equivalent to a predicate device and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance with manufacturing practices. It also includes an "Indication for Use" section.

However, it does not include:

  • A table of acceptance criteria and reported device performance.
  • Information about sample sizes for test or training sets.
  • Details on data provenance or ground truth establishment.
  • The number or qualifications of experts used.
  • Adjudication methods.
  • Information about multi-reader multi-case (MRMC) studies or standalone performance.

The document is a regulatory approval, not a scientific study report or a detailed performance and validation document. Therefore, I cannot extract the specific information you are looking for from this text.

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.