CARESIDE AST

K990009 · Careside, Inc. · CIT · Mar 16, 1999 · Clinical Chemistry

Device Facts

• Record ID: K990009
• Device Name: CARESIDE AST
• Applicant: Careside, Inc.
• Product Code: CIT · Clinical Chemistry
• Decision Date: Mar 16, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1100
• Device Class: Class 2

Intended Use

For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure AST from anti-coagulated whole blood, plasma, or serum specimens to measure AST from and-coagulated with croos, pertain types of liver and heart ald in the diagnosis and treatment of patients with ouse: not for point of care or physician office laboratory use.

Device Story

CARESIDE™ AST is an in vitro diagnostic test system for quantitative measurement of aspartate aminotransferase (AST) levels. The device utilizes dry film chemistry technology to monitor analyte-specific biochemical reactions. It processes anti-coagulated whole blood, plasma, or serum samples. The system is intended for use with the CARESIDE Analyzer. Results are used by clinicians to aid in the diagnosis and treatment of liver and heart disease. The device is restricted to professional laboratory settings and is not intended for point-of-care or physician office use.

Clinical Evidence

Quantitative method comparison performed against Raichem and Sigma Diagnostics Aspartate Aminotransferase methods. No clinical prospective or retrospective study data provided in the summary.

Technological Characteristics

Dry film chemistry assay for AST measurement. Designed for use with the CARESIDE Analyzer. Does not utilize pyridoxal-5-phosphate supplementation. Regulatory class II, 21 CFR 862.1100.

Indications for Use

Indicated for quantitative measurement of AST in anti-coagulated whole blood, plasma, or serum to aid in diagnosis and treatment of liver and heart disease. Not for point-of-care or physician office laboratory use.

Regulatory Classification

Identification

An aspartate amino transferase (AST/SGOT) test system is a device intended to measure the activity of the enzyme aspartate amino transferase (AST) (also known as a serum glutamic oxaloacetic transferase or SGOT) in serum and plasma. Aspartate amino transferase measurements are used in the diagnosis and treatment of certain types of liver and heart disease.

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.

Predicate Devices

• Vitros AST DT Slides for Johnson and Johnson's Vitros DT 60 II / DTSC II (K912844)

Reference Devices

• Raichem Aspartate Aminotransferase method
• Sigma Diagnostics Aspartate Aminotransferase method

Submission Summary (Full Text)

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K 99009

# 510(K) SUMMARY: CARESIDE™ AST SAFETY AND IV. EFFECTIVENESS

#### I. Applicant Information

- A. Applicant Name
- Applicant/Manufacturer Address B.
- C. Telephone Number
- Contact Person D.
- FAX Number E.
- F. e-Mail Address
- Date 510(k) Summary prepared G.

#### Device Information II.

- A. Device Name (Trade)
- Device Name (Classification) B.
- C. Device Classification

# CARESIDE, Inc. 6100 Bristol Parkway Culver City, CA 90230 310-338-6767 Kenneth B. Asarch, Pharm.D., Ph.D. 310-338-6789 [e-mail] December 30, 1998

# CARESIDE™ AST

Aspartate amino transferase test system Clinical chemistry panel Aspartate amino transferase test system Regulation Number: 21 CFR 862.1100 Regulatory Class II Classification Number: to be assigned None applicable

#### D. Special controls and performance standards

#### III. Substantial Equivalence Claim

- A. General equivalency claim
The ability to monitor analyte-specific biochemical reactions in dry film and other formats is widely recognized and has gained widespread acceptance for use in chemistry assays.

AST in vitro diagnostic products, in both dry film and other formats, are already on the U.S. market.

- B. Specific equivalency claim
The CARESIDE™ AST test is substantially equivalent in its principle, intended use, and clinical performance to the currently marketed Vitros slides for the quantitative measurement of AST on the Vitros DT 60 II / DTSC II. A quantitative method comparison is provided to the Raichem Aspartate Aminotransferase method and the Sigma Diagnostics Aspartate Aminotransferase method rather than the Vitros method because the CARESIDE, Raichem, and Sigma Diagnostics methods all measure the reaction without supplementation of the co-factor pyridoxal-5-phosphate. Whereas, the Vitros DT 60 II method uses pyridoxal-5-phosphate supplementation and thus is expected to yield higher results.

Johnson and Johnson's (formerly Eastman Kodak, Name of Predicate Device: Inc.) Vitros AST DT Slides for Johnson and Johnson's Vitros DT 60 II / DTSC II (formerly Eastman Kodak's DT 60 II).

Predicate Device 510K number: K912844/A Product Code: 75CIT

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MAR 1 6 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Kenneth B. Asarch, Pharm.D., Ph.D. VP Quality Systems and Regulatory Affairs CARESIDE, INC. 6100 Bristol Parkway Culver City, CA 90230

K990009 Re: Trade Name: CARESIDE™ AST Regulatory Class: II Product Code: CIT Dated: December 30, 1998 Received: January 4, 1999

Dear Dr. Asarch:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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# Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Autman

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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### INDICATIONS FOR USE VI.

510(k) Number:

K9990009 CARESIDE™ AST

Device Name:

Indications for use:

For in vitro diagnostic use with the CARESIDE Analyzer™ to quantitatively measure AST from anti-coagulated whole blood, plasma, or serum specimens to measure AST from and-coagulated with croos, pertain types of liver and heart ald in the diagnosis and treatment of patients with ouse: not for point of care or physician office laboratory use.

Jean Cooger
(Division Sign-Off)
Division of Clinical

(Division of Clinical Laboratory Devices
510(k) Number 510(k) Number _ K 990 009

# (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)

Over-The-Counter Use (Optional Format 1-2-96)