CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3

K083554 · Cliniqa Corporation · JJY · Apr 21, 2009 · Clinical Chemistry

Device Facts

• Record ID: K083554
• Device Name: CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 21, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the performance of clinical methods for immunoassay analytes listed in the product insert.

Device Story

CLINIQA® Liquid QC™ ImmunoAssay Controls are serum-based, multi-analyte quality control products provided at three levels. Used in clinical laboratories to monitor analytical system performance within the clinical range. Controls contain human source material tested for HBsAg, HIV-1 antigen, HCV antibody, and HIV-1/2 antibody. Product is supplied in 5 mL vials. Healthcare providers use the controls to verify assay performance; results are compared against lot-specific expected ranges provided in the package insert to ensure analytical accuracy and reliability.

Clinical Evidence

No clinical data. Bench testing only. Stability protocols reviewed and found adequate. Accelerated stability data supports unopened vial storage of 3.0 years at -20°C and open vial stability of 30 days at 2-8°C (with exceptions for free PSA [7 days], insulin [15 days], and folate [15 days]).

Technological Characteristics

Serum-based liquid control material containing human source constituents. Provided in three levels. Stability established via accelerated testing. No specific materials standards or software algorithms described.

Indications for Use

Indicated for use as an assayed, liquid quality control product to evaluate the performance of clinical laboratory assays for specific analytes listed in the product insert. For prescription use only.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 2 1 2009

Ms. Dawn Gast Quality Manager CLINIQA Corporation 288 Distribution Street San Marcos, CA 92078

k083554 Re:

> Trade name: CLINIQA® Liquid QC™ Immunoassay Control Level 1, 2 and 3 Regulation Number: 21 CFR 862.1600 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Code: JJY Dated: April 9, 2009 Received: April 13, 2009

Dear Ms. Gast:

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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

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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 advice for your device on our labeling regulation (21 CFR Part 801), 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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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/industry/support/index.html.

Sincerely vours.

C/a

Courtney C. Harper, Ph.D. Acting 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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## Indications for Use

510(k) Number (if known): k083554

Device Name: CLINIQA® LiquidQC™ Immunoassay Control Level 1, 2, and 3

Indications For Use:

CLINIQA® Liquid QC™ ImmunoAssay Controls, Levels 1, 2, & 3 are assayed, liquid, quality control products which may be used to evaluate the assaycu, liquid, quality control procuments an analytes listed in the product insert.

Prescription Use _ × CFR 801 Subpart D)

Over-The-Counter Use _________ (Part 21 AND/OR 21 CFR 807 Subpart C)

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

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

Tracy Phillips
Sign-Off Pa

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K083554