LogoFDA 510(k) Search
K Number
K973072
Device Name
WAKO NEFA LINEARITY SET
Manufacturer
WAKO CHEMICALS, USA, INC.
Date Cleared
1997-09-12

(25 days)

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

The Wako NEFA Linearity set is to be used with the Wako NEFAC test kit for the estimation of the linearity limits of the reagent/instrument system for the NEFA analyte.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the "Wako NEFA Linearity Set," indicating it is substantially equivalent to a predicate device.

Specifically, the document mentions:

  • Device Name: Wako NEFA Linearity Set
  • Indications For Use: "The Wako NEFA Linearity set is to be used with the Wako NEFA C test kit for the estimation of the linearity limits of the reagent/instrument system for the NEFA analyte."

However, it does not include:

  1. A table of acceptance criteria or reported device performance.
  2. Details on sample sizes, data provenance, or study design.
  3. Information about experts, ground truth establishment, or adjudication methods.
  4. Reference to multi-reader multi-case (MRMC) comparative effectiveness studies.
  5. Information about standalone algorithm performance.
  6. Details on training set size or how its ground truth was established.

This document is a regulatory approval letter, not a technical study report. To get the information you are requesting, you would need to consult a separate study report or technical documentation for the Wako NEFA Linearity Set.

§ 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.