CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3

• K Number: K070741
• Device Name: CLINIQA LIQUID QC UNASSAYED AND ASSAYED GENERAL CHEMISTRY CONTROL LEVELS 1, 2, & 3
• Manufacturer: CLINIQA CORPORATION
• Date Cleared: 2007-05-04 ( 49 days)
• Product Code: JJY
• Regulation Number: 862.1660
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

CLINIQA® Liquid QC™ Assayed General Chemistry Control is intended for use as an assayed quality control material for the contituents listed in this package insert.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.

The document is a 510(k) clearance letter from the FDA for "Cliniqa Liquid QC Assayed and Unassayed General Chemistry Control Levels 1, 2 & 3." It confirms that the device is substantially equivalent to legally marketed predicate devices.

While it mentions "indications for use," it does not include details about:

• Specific acceptance criteria (table form or otherwise)
• Reported device performance metrics
• Sample sizes for test sets or training sets
• Data provenance
• Number or qualifications of experts
• Adjudication methods
• MRMC comparative effectiveness studies or effect sizes
• Standalone algorithm performance
• Types of ground truth used or how ground truth was established

This document is a regulatory approval notice, not a study report detailing performance data.

Regulation Number and Section

§ 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.