LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS by CLINIQA CORPORATION

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

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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.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 1 2003

Ms. Carol Ruggiero Director of Regulatory Affairs CLINIQA Corporation 1432-B South Mission Road Fallbrook, CA 92028

Re: K032074

Trade/Device Name: LiniCAL™ Esoterics Calibration Verifiers Levels A -E for Beckman Coulter Synchron ® Analyzers Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: October 1, 2003 Received: October 3, 2003

Dear Ms. Ruggiero:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

032074

Device Name: LiniCAL ™ Esoterics Calibration Verifiers Levels A – E for Beckman Coulter Synchron® Analyzers

Indications For Use:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C Benson for Jean Cooper, DVM
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K032074

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

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.