CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED

K060322 · Cliniqa Corporation · JIT · Mar 21, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060322
• Device Name: CLINIQA DRY QC CHEMISTRY CONTROL, LEVELS 1 AND 2, ASSAYED, CLINIQA DRY QC CHEMISTRY CONTROL, LEVEL 1 AND 2 UNASSAYED
• Applicant: Cliniqa Corporation
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 21, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Assayed ), is intended for use as an assayed quality control material. Two levels of the control are provided. CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided. CLINIQA QALIBRATE™ - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers .

Device Story

CLINIQA Dry QC™ Chemistry Control (Assayed/Unassayed) and QALIBRATE™-CH Chemistry Calibrator are in vitro diagnostic products. Controls serve as quality control material to monitor performance of clinical chemistry analyzers; calibrators are used to establish assay method calibration. Used in clinical laboratory settings by laboratory professionals. Products provide known values or reference points to ensure accuracy and precision of clinical chemistry testing. Benefits include verification of analytical system performance and reliable patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized or dry chemistry control and calibrator materials. Intended for use with clinical chemistry analyzers. Class II device, product codes JIT and JJY.

Indications for Use

Indicated for use as quality control material (assayed and unassayed) and for assay method calibration in clinical chemistry analyzers. No specific patient population, age, or gender restrictions stated.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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

MAR 2 1 2006

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

Re: k060322

Trade/Device Name: CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2, Assayed CLINIOA Dry QC™ Chemistry Control, Levels 1 and 2, Unassayed CLINIQA QUALIBRATE™- CH Chemistry Calibrator Regulation Number: 21 CFR§ 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class II Product Code: JIT, JJY Dated: February 3, 2006 Received: February 9, 2006

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

Sincerely yours,

Alberto Garcia

Alberto Gutierrez, Ph.D. 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 Dry QC™ Chemistry Control, Levels 1 and 2, Assayed

Indications For Use:

CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Assayed ), is intended for use as an assayed quality control material. Two levels of the control are provided.

Device Name: CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2, Unassayed

Indications For Use:

CLINIQA Dry QC™ Chemistry Control, Levels 1 and 2 (Unassayed) is intended for use as a quality control material. Two levels of the control are provided.

Device Name: CLINIQA QALIBRATE™ - CH Chemistry Calibrator

Indications For Use:

CLINIQA QALIBRATE™ - CH Chemistry Calibrator is intended for use in assay method calibration for clinical chemistry analyzers .

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

K060322