CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL

K030705 · Cliniqa Corporation · JJY · Mar 26, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030705
• Device Name: CLINIQA LIQUID QC TUMOR MARKER CONTROL LEVEL 1, LEVEL 2, LEVEL 3, AND TRI LEVEL
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA Liquid QC™ Tumor Marker Control for serum protein and tumor marker analysis is intended for use as an assayed quality control material for serum protein and tumor marker analysis

Device Story

CLINIQA Liquid QC™ Tumor Marker Control is a multi-analyte, liquid, tri-level control material. Used in clinical laboratories to monitor the precision and accuracy of serum protein and tumor marker analysis assays. Functions as an assayed quality control material to verify performance of diagnostic test systems. Provides clinicians and laboratory technicians with a reference to validate analytical results; ensures reliability of patient testing. No specific patient interaction; used exclusively for laboratory quality assurance.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, tri-level, multi-analyte control material. Designed for serum protein and tumor marker analysis. Classified under 21 CFR 862.1660 (Product Code JJY).

Indications for Use

Indicated for use as an assayed quality control material for serum protein and tumor marker analysis 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)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle head facing left, with three parallel lines extending from the back of the head, resembling feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle head.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

## MAR 2 6 2003

k030705 Re: Trade/Device Name: CLINIQA Liquid QC™ Tumor Marker Control Level 1 CLINIQA Liquid QC™ Tumor Marker Control Level 2 CLINIOA Liquid OC™ Tumor Marker Control Level 3 CLINIQA Liquid QCTM Tumor Marker Control Level, Tri-Level Regulation Number: 21 CFR § 862.1660

Regulation Name: Multi Analyte Controls (Assayed and unassayed) Regulatory Class: I Product Code: JJY Dated: March 5, 2003 Received: March 6, 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). 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.

{1}------------------------------------------------

Page 2 -

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

{2}------------------------------------------------

510(k) Number (if known): K 030 7 05

CLINIQA Liquid QC™ Tumor Marker Control Level 1 Device Name: CLINIQA Liquid QC™ Tumor Marker Control Level 2 CLINIQA Liquid QC™ Tumor Marker Control Level 3 CLINIQA Liquid QC™ Tumor Marker Control, Tri- Level

Indications For Use:

CLINIQA Liquid QC™ Tumor Marker Control for serum protein and tumor marker analysis is intended for use as an assayed quality control material for serum protein and tumor marker analysis

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

AP Reeves for S. Bautista

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K030705

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use