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K Number
K032074
Device Name
LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS
Manufacturer
CLINIQA CORPORATION
Date Cleared
2003-10-21

(106 days)

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

CLINIQA LiniCAL™ Esoterics Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Beckman Coulter Synchron® Analyzers. Five assayed levels of AMM (ammonia), ETOH (alcohol), MA (microalbumin), M-TP (microprotein) and SALY (salicylate) are provided to allow monitoring of the reportable range.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA for a device called "LiniCAL™ Esoterics Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Analyzers." This is a quality control material used to verify calibration and assess linearity of clinical analyzers.

The provided text does not contain the detailed study information required to answer your request. It primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices. It does not include:

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

Therefore, I cannot provide the requested information based on the given document. This document is a regulatory approval letter, not a study report.

§ 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.