CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL

K030768 · Cliniqa Corporation · JJT · Mar 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030768
• Device Name: CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVEL
• Applicant: Cliniqa Corporation
• Product Code: JJT · Clinical Chemistry
• Decision Date: Mar 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL is intended for use as an assayed quality control material for analysis.

Device Story

CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL functions as an assayed quality control material; used by clinical laboratory professionals to monitor the precision and accuracy of cardiac marker analytical procedures; provides known values for comparison against patient sample results; helps ensure reliability of diagnostic testing; liquid format; used in clinical laboratory environments.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Liquid quality control material; assayed for cardiac markers; provided in three levels; intended for in vitro diagnostic use.

Indications for Use

Indicated for use as an assayed quality control material for the analysis of cardiac markers in clinical laboratory settings.

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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

MAR 21 2003

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

Re: k030768

Trade/Device Name: CLINIQA Liquid QC™ Cardiac Marker Controls Levels 1,2 & 3 Tri-LEVEL Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJT Dated: March 10, 2003 Received: March 11, 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. Iisting 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 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):

K030768

Device Name: CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL

Indications For Use:

CLINIQA Liquid QC™ Cardiac Marker Control Levels 1, 2 & 3 Tri-LEVEL is intended for use as an assayed quality control material for analysis.

Alan Cooper

I ahora 510(k) Number

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use