CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3

K022232 · Cliniqa Corporation · JJX · Aug 1, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022232
• Device Name: CLINIQA LIQUID-QC HCG CONTROL LEVEL 1, 2, AND 3
• Applicant: Cliniqa Corporation
• Product Code: JJX · Clinical Chemistry
• Decision Date: Aug 1, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

CLINIQA Liquid-QC™ hCG Control is intended for use as an assayed quality control material for serum Human Chorionic Gonadotropin protein analysis, which is used to monitor the accuracy and precision of procedures in use in the clinical laboratory.

Device Story

CLINIQA Liquid-QC™ hCG Control is an assayed quality control material used in clinical laboratories to monitor the accuracy and precision of serum hCG testing procedures. The product consists of three levels of control material. It is intended for professional use by laboratory personnel to verify the performance of diagnostic assays. By providing known values for hCG, the control allows clinicians to assess the reliability of patient test results, ensuring that laboratory procedures remain within established performance specifications.

Clinical Evidence

bench testing only

Technological Characteristics

Liquid-based quality control material; assayed for serum Human Chorionic Gonadotropin (hCG) protein; provided in three distinct levels; intended for in vitro diagnostic use.

Indications for Use

Indicated for use as an assayed quality control material for serum Human Chorionic Gonadotropin (hCG) protein analysis to monitor the accuracy and precision of clinical laboratory testing procedures.

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 is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 01 2002

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

k022232 Re:

Trade/Device Name: CLINIQA Liquid-QC™ hCG Control Levels 1 CLINIQA Liquid-QCTM hCG Control Levels 2 CLINIQA Liquid-QCTM hCG Control Levels 3 Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unasayed) Regulatory Class: Class I, reserved Product Code: JJX Dated: July 3, 2002 Received: July 10, 2002

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 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 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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 Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): KOJJJ232

Device Name:

## CLINIQA Liquid-QC™ hCG Control Level 1 CLINIQA Liquid-QC™ hCG Control Level 2 CLINIQA Liquid-QC™ hCG Control Level 3

Indications For Use:

CLINIQA Liquid-QC™ hCG Control is intended for use as an assayed quality control material for serum Human Chorionic Gonadotropin protein analysis, which is used to monitor the accuracy and precision of procedures in use in the clinical laboratory.

(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

for Joe Kennel Sheriff
(Division Sign Off)

ivision Sign-Off) Division of Clinical Laboratory Devices

510(k) Number Lezzzz