LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS

K031577 · Cliniqa Corporation · JJY · Aug 6, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031577
• Device Name: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY PROTEIN SYSTEMS
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 6, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The LiniCAL Protein 2 Calibration Verifiers Levels A – E for Beckman Coulter Array Protein Systems is intended for use as an assayed quality control material for analysis.

Device Story

LiniCAL™ Protein 2 Calibration Verifiers are assayed quality control materials used in clinical laboratory settings. The device serves as a reference to verify the calibration and performance of Beckman Coulter Array® Protein Systems. Laboratory technicians use the product to monitor the accuracy and precision of protein analysis assays. By comparing system results against the provided assayed values, the device helps ensure the reliability of patient sample testing, thereby supporting accurate clinical decision-making by healthcare providers.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Serum-based quality control material; five assayed levels; contains Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Antithrombin III, Beta-2-Macroglobulin, and Ceruloplasmin. Designed for use with Beckman Coulter Array Protein Systems.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the reportable range of Alpha-1-Acid Glycoprotein, Alpha-1-Antitrypsin, Alpha-2-Macroglobulin, Antithrombin III, Beta-2-Macroglobulin, and Ceruloplasmin on Beckman Coulter Array Protein Systems.

Regulatory Classification

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.

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG - 6 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k031577

> Trade/Device Name: LiniCAL™ Protein 2 Calibration Verifiers Levels A-E for Beckman Coulter Array® Protein Systems Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I Product Code: JJY Dated: May 16, 2003 Received: June 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). 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.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

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): KO 315 77

Device Name: LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for Beckman Coulter Array® Protein Systems

Indications For Use:

LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for Beckman Coulter Array® Protein Systems is intended for use as an assayed quality control material for analysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Carol C Benen/Jean Cooper, DVM
Division Sign-Off

Office of In Vitre Diagnostic Device Evaluation and Safety

vk K031577

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use