LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS

K040535 · Cliniqa Corporation · JJY · Mar 29, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040535
• Device Name: LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS
• Applicant: Cliniqa Corporation
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

LiniCAL™ Enzyme Calibration Verifiers Levels A-E for Beckman Coulter Synchron® Systems are assayed, liquid quality control products which may be used to evaluate the performance of the Beckman Coulter Synchron® Systems for alkaline phosphatase, alanine aminotransferase, amylase, aspartate aminotransferase, cholinesterase, creatine kinase, creatine kinase MB, lactic dehydrogenase, lipase, gamma glutamyl transferase, and pancreatic amylase at five useful concentrations.

Device Story

LiniCAL™ Enzyme Calibration Verifiers are liquid, assayed quality control products used to monitor the performance of Beckman Coulter Synchron® clinical chemistry systems. The device provides five distinct concentration levels for a panel of enzymes, including Alkaline Phosphatase, ALT, Amylase, AST, Cholinesterase, CK, CK-MB, LDH, Lipase, GGT, and Pancreatic Amylase. Used in clinical laboratory settings by laboratory technicians to verify instrument accuracy and precision. The healthcare provider compares the measured values of the verifiers against expected ranges to ensure the system is operating within specifications, thereby supporting the reliability of patient diagnostic test results.

Clinical Evidence

No clinical data. Bench testing only. Stability was determined using the Arrhenius model of accelerated elevated temperature studies to estimate storage stability at 2-8°C. Unopened vial stability is estimated at 3 years; opened vial stability is 14 days at 2-8°C.

Technological Characteristics

Human serum protein-based liquid; contains preservatives, stabilizers, and sodium azide. Manufactured without glycerol or glycol. Five levels (A-E) of constituent concentrations. Stability validated via Arrhenius model. Designed for use with Beckman Coulter Synchron® Systems.

Indications for Use

Indicated for use as assayed, liquid quality control products to evaluate the performance of Beckman Coulter Synchron® Systems for specific enzyme assays (Alkaline Phosphatase, ALT, Amylase, AST, Cholinesterase, CK, CK-MB, LDH, Lipase, GGT, and Pancreatic Amylase) at five concentrations. No specific patient population or contraindications provided.

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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Public Health Service

MAR 2 9 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

Re: k040535

> Trade/Device Name: LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed). Regulatory Class: Class I Product Code: JJY Dated: March 1, 2004 Received: March 2, 2004

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/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, MS, DVM.

Yean M. Cooper, MS, D.V.M. 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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K040535 510(k) Number (if known):

Device Name: LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems

Indications For Use:

CLINIQA LiniCAL™ Enzyme Calibration Verifiers Levels A - E for Beckman Coulter Synchron® Systems are assayed, liquid, quality control products which may be used to evaluate the performance of the Beckman Coulter Synchron® System for Alkaline Phosphatase, Alanine Aminotransferase, Amylase, Aspartate Aminotransferase, Cholinesterase, Creatine Kinase, Creatine Kinase MB, Lactate Dehydrogenase, Lipase, Gamma Glutamyl Tranferase, and Pancreatic Amylase at five useful concentrations.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Qeet. D. Heen and for Heen Cooper
**Division Sign-Off**

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040535

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use