K-ASSAY APO AI by KAMIYA BIOMEDICAL CO.

The K-ASSAY Apo Al Assay is intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay. Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases. FOR IN VITRO DIAGNOSTIC USE.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance letter (K993345) for the K-ASSAY Apo AI Assay primarily focuses on establishing substantial equivalence to a predicate device. It does not contain the detailed information required to describe the acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical study report or a detailed 510(k) summary.

Specifically, the document does NOT provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts, their qualifications, or adjudication methods for establishing ground truth.
Information about multi-reader multi-case (MRMC) studies or standalone algorithm performance.
Type of ground truth used.
Sample size for the training set or how its ground truth was established.

The letter states the device is "intended to be used for the quantitative determination of Apo Al in human serum by immunoturbidimetric assay" and that "Apolipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases." This describes the intended use and clinical utility, but not performance metrics or study details.

To obtain the requested information, one would typically need to consult the complete 510(k) submission summary, which sometimes contains a more detailed description of the analytical and clinical studies performed to support the substantial equivalence claim. This particular clearance letter is a high-level official communication, not a scientific publication detailing study methodology and results.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 5 1999

Mr. Colin Getty Official Correspondent Kamiya Biomedical Company 910 Industry Drive Seattle, Washington 98188

Re: K993345

Trade Name: K-ASSAY Apo AI Assay Regulatory Class: II Product Code: DER Dated: October 1, 1999 Received: October 5, 1999

Dear Mr. Getty:

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 Regulations, 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 regulation 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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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 Putman

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 STATEMENT

510(k) Number (if known): K993345

Device Name: K-ASSAY Apo Al.

Indications for Use:

Secan Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K993345

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Optional Format 1-2-96)

Regulation Number and Section

§ 866.5580

Alpha -1-lipoprotein immunological test system.(a)
Identification. Analpha -1-lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha- 1-lipoprotein (high-density lipoprotein) in serum and plasma. Measurement ofalpha- 1-lipoprotein may aid in the diagnosis of Tangier disease (a hereditary disorder of fat metabolism).(b)
Classification. Class II (performance standards).