LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS

K031575 · Cliniqa Corporation · JJY · Jul 23, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031575
• Device Name: LINICAL PROTEIN 2 CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU ANALYZERS
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the Olympus ®AU Analyzers. Five assayed levels of Anti Streptolysin O, C-Reactive protein, Compliment C3, Compliment C4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of reportable range.

Device Story

LiniCAL™ Protein 2 Calibration Verifiers consist of five assayed levels of specific human-derived proteins; used in clinical laboratories to verify calibration and assess linearity of Olympus® AU Analyzers. Device provides a reference material to monitor the reportable range of clinical chemistry assays. Laboratory technicians use the verifiers to ensure instrument accuracy; results allow clinicians to validate patient test values within the analytical measurement range. Benefits include improved confidence in diagnostic accuracy for protein-based assays.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Human serum-based liquid material; contains sodium azide preservative. Five-level concentration matrix. Optimized for Olympus AU Analyzers. Traceable to IFCC CRM 470 and WHO standards. Evaluated per NCCLS EP6 linearity standards.

Indications for Use

Indicated for use in clinical laboratories to verify calibration and assess linearity of Olympus® AU Analyzers for specific protein analytes (ASO, CRP, C3, C4, Ferritin, IgA, IgG, IgM, Prealbumin, Transferrin). No specific patient population or contraindications stated.

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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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

JUL 2 3 2003

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k031575

Trade/Device Name: LiniCAL™ Protein 2 Calibration Verifiers Levels A - E for Olympus® AU Analyzers 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):

Device Name: LiniCAL™ Protein 2 Calibration Verifiers Levels A – E for Olympus® AU Analyzers

Indications For Use:

CLINIQA LiniCAL™ Protein 2 Calibration Verifiers are intended for use in the clinical Iaboratory to verify calibration and/or assess linearity of the Olympus® AU Analyzers. Five assayed levels of Anti Streptolysin O, C-Reactive Protein, Complement C3, Complement C4, Ferritin, Immunoglobulin A, Immunoglobulin G, Immunoglobulin M, Prealbumin and Transferrin are provided to allow monitoring of the reportable range.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Reeves for L. Bautista

Division of Clinical Laboratory Devices

510(k) Number K031575

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use