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 Description

Not Found

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CARESIDE™ AST device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values. Instead, it states a "Specific equivalency claim" based on principle, intended use, and clinical performance. The study for clinical performance is a quantitative method comparison.

Acceptance Criteria (Implicit from Specific Equivalency Claim): The CARESIDE™ AST test should be substantially equivalent in its principle, intended use, and clinical performance to the currently marketed Vitros slides for AST measurement.
Reported Device Performance (Implicit from Method Comparison): The document indicates that a "quantitative method comparison" was performed against the Raichem Aspartate Aminotransferase method and the Sigma Diagnostics Aspartate Aminotransferase method. The results of this comparison are not explicitly tabulated or detailed in the provided text, but the conclusion of the FDA's 510(k) review is that the device is "substantially equivalent," implying the performance met the necessary criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the method comparison or the provenance (e.g., country of origin, retrospective/prospective) of the data. It only mentions that a "quantitative method comparison is provided."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided. The study is a quantitative method comparison against established reference methods (Raichem and Sigma Diagnostics methods), which serve as the "ground truth" or comparative standard. It does not involve human expert interpretation of results to establish ground truth in the same way an imaging study might.

4. Adjudication Method for the Test Set

Not applicable. As a quantitative method comparison, there isn't an "adjudication method" in the sense of reconciling differences between human expert interpretations. The comparison is against established laboratory methods.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with AI in interpretation tasks where human readers' performance is evaluated with and without AI assistance (e.g., radiology). The CARESIDE™ AST is an in vitro diagnostic device for quantitative chemical analysis, so an MRMC study is not relevant.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

Yes, a standalone performance assessment was done. The "quantitative method comparison" evaluates the CARESIDE™ AST device (algorithm/method only) directly against established laboratory methods. It's designed to measure the analytical performance of the device itself, independent of human interpretation once the test is run.

7. The Type of Ground Truth Used

The ground truth used for the method comparison study was established by established reference methods: the Raichem Aspartate Aminotransferase method and the Sigma Diagnostics Aspartate Aminotransferase method. These methods are themselves validated laboratory procedures for measuring AST.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" sample size. For an in vitro diagnostic device like the CARESIDE™ AST, the development process might involve internal validation and optimization, but the document focuses on the clinical performance study for regulatory submission, which is typically a test or validation set comparing the device to a reference.

9. How the Ground Truth for the Training Set Was Established

Since no specific "training set" information is provided related to the regulatory submission, the method for establishing its ground truth is also not detailed. Any internal development or training would likely rely on similar principles of comparing results to established laboratory methods or certified reference materials to optimize performance characteristics.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten date of 3/15/99 at the top left. Below the date, the text "CARESIDE, Inc." is printed in bold. Underneath "CARESIDE, Inc.", the text "Page 10" is printed.

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 AsarchK@CARESIDE.com 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 (770) 488-7655.

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 (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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:

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)

Regulation Number and Section

§ 862.1100 Aspartate amino transferase (AST/SGOT) test system.

(a)
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.(b)
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.