CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC

K080973 · Cliniqa Corporation · JJY · Jun 2, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080973
• Device Name: CLINIQA LIQUID QC COMPLETE CARDIAC MARKER CONTROL, LEVELS 1,2, AND 3; CARDIAC MARKER CONTROL-LOW, AND LINICAL CARDIAC
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA® Liquid QC™ Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for use as a standard. CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for use as a standard. LiniCAL Cardiac Marker Calibration Verifiers, Levels A-D are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product insert are provided to allow monitoring of the reportable range

Device Story

Liquid quality control materials and calibration verifiers; human plasma protein matrix base; fortified with human source materials and reagent grade chemicals; includes preservatives, stabilizers, and sodium azide. Ready-to-use liquid format; no reconstitution required. Used in clinical laboratories to monitor cardiac marker assay performance, verify calibration, and assess linearity of specific analyzers (e.g., Biosite Triage, Roche Integra, Roche Elecsys). Healthcare providers use recovered values to ensure instrument accuracy and reportable range validity. Donor units tested non-reactive for HBsAg, HIV-1 antigen, HCV, and HIV-1/2 antibodies.

Clinical Evidence

No clinical data. Bench testing only. Stability protocols reviewed and deemed adequate. Real-time stability data (8 months) supports a 2.0-year shelf life claim. Open-vial stability established at 30 days when stored at 2-8°C.

Technological Characteristics

Liquid, assayed quality control material and calibration verifiers. Formulated for cardiac marker analytes. Intended for use with clinical laboratory analyzers. No specific materials of construction, energy sources, or software algorithms described.

Indications for Use

Indicated for use in clinical laboratories as assayed quality control material to monitor cardiac marker assay performance and as calibration verifiers to assess linearity and verify calibration of specified clinical analyzers.

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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## Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

CLINIOA Corp. c/o Ms. Carol Ruggiero Director of Regulatory Affairs 774 North Twin Oaks Valley Road San Marcos, CA 92069

JUN - 2 2008

Re: k080973

Trade Name: Cliniqa Liquid QC Complete Cardiac Marker Control, Levels 1, 2, and 3, Cliniqa LiniCal Cardiac Marker Calibration Verifiers, Levels A-D, Cliniqa Liquid QC Cardiac Marker Control-Low Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I (reserved) Product Code: JJY Dated: April 03, 2008 Received: April 04, 2008

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 [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 at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Jean M. Cooper, M.S., D.v.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology 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: CLINIQA Liquid QC Complete Cardiac Marker Control, Levels 1, 2, and 3

## Indications For Use:

CLINIQA® Liquid QC™ Complete Cardiac Marker Control Levels 1, 2, and 3 is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liquid QC Complete Cardiac Marker Control is not intended for uroud a standard.

Device Name: CLINIQA LiniCAL Cardiac Marker Calibration Verifiers, Levels A-D

Indications For Use:

LiniCAL Cardiac Marker Calibration Verifiers are intended for use in the clinical laboratory to verify calibration and/or assess linearity of the analyzers listed in the product insert. Four assayed levels of analytes listed in the product inert are provided to allow monitoring of the

reportable range.

Device Name: CLINIQA Liquid QC Cardiac Marker Control - Low

Indications For Use:

CLINIQA Liquid QC Cardiac Marker Controls, Low is intended for use as an assayed quality control material for cardiac markers listed in the product insert. CLINIQA Liguid QC Complete Cardiac Marker Control is not intended for use as a standard.

| Prescription Use | X |
|-----------------------------|---|
| (Part 21 CFR 801 Subpart D) | |

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Carol C. Benson
Sign-Off

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rrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)