LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE

K013332 · Cliniqa Corporation · JJY · Nov 20, 2001 · Clinical Chemistry

Device Facts

• Record ID: K013332
• Device Name: LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Nov 20, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

LiniCAL™ Protein I Calibration Verifiers Levels A – E for Beckman Coulter Immage™ is intended for use as an assayed quality control material for analysis.

Device Story

LiniCAL™ Protein I Calibration Verifiers are assayed quality control materials used to verify the calibration and performance of the Beckman Coulter Immage™ system. The product consists of five levels (A-E) of control material. It is used by laboratory professionals in clinical settings to monitor the accuracy and precision of analytical assays. By comparing observed results against established target values, the device assists in validating the performance of the diagnostic system, ensuring reliable clinical decision-making for patient testing.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed quality control material provided in five levels (A-E). Designed for use with the Beckman Coulter Immage™ system. No specific materials of construction, energy sources, or software algorithms are described.

Indications for Use

Indicated for use as an assayed quality control material for 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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

NOV 2 0 2001

K013332 Re:

Trade/Device Name: LiniCAL™ Protein I Calibration Verifiers Levels A-E for Beckman

Coulter Immage™ Regulation Number: 21 CFR § 862.1660 Regulation Name: Quality Control Material (Assayed and Unassayed) Regulatory Class: I. Reserved Product Code: JJY Dated: October 4, 2001 Received: October 9, 2001

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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## NOV 2 0 2001

## 510(k) Number (if known): K(0) 13332

## Device Name: LiniCAL™ Protein I Calibration Verifiers Levels A – E for Beckman Coulter Immage™

Indications For Use:

LiniCAL™ Protein I Calibration Verifiers Levels A – E for Beckman Coulter Immage™ is intended for use as an assayed quality control material for analysis.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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oratory Devices

Number K013332

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use