DIRECT HDL-CHOLESTEROL REAGENT by KAMIYA BIOMEDICAL CO.

The K-ASSAY Direct HDL-Cholesterol reagent is intended for the quantitative in vitro determination of HDL-cholesterol in serum or plasma which is used in the diagnosis and treatment of lipid disorders.

The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

Device Description

K-Assay Direct HDL-Cholesterol Reagent K-Assay Direct HDL-Cholesterol Calibrator

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "K-Assay Direct HDL-Cholesterol Reagent and Calibrator". This type of document does not contain the detailed information about acceptance criteria or specific study results that you are requesting.

Here's why and what information is typically missing:

Why this document doesn't have the requested information:

510(k) Clearance: A 510(k) clearance primarily focuses on demonstrating "substantial equivalence" to a predicate device already on the market. It's not a pre-market approval (PMA) and doesn't require the same depth of clinical study data to be submitted or publicly summarized in the clearance letter itself.
Regulatory Focus: The letter confirms that the device can be marketed because it meets the regulatory requirements for substantial equivalence. It refers to the "indications for use" but doesn't detail the specific performance studies that underpinned those claims.
Proprietary Information: Detailed study results, acceptance criteria, and ground truth methodologies are often considered proprietary by the manufacturer and are submitted to the FDA confidentially. They are rarely fully disclosed in the public 510(k) clearance letter.

Therefore, I cannot extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: This document only states the device's intended use for quantitative determination of HDL-cholesterol. It does not provide performance metrics like accuracy, precision, sensitivity, specificity, or the acceptance criteria for these.
Sample size used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not applicable for an in vitro diagnostic reagent like this. MRMC studies are typically for imaging devices where human interpretation is involved.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for an in vitro diagnostic reagent. Its performance is inherent to the chemical assay itself.
The type of ground truth used: Not mentioned. For a diagnostic assay, the "ground truth" would likely be established by a reference method for HDL-cholesterol.
The sample size for the training set: Not mentioned. In the context of an in vitro diagnostic reagent, there isn't typically a "training set" in the same way an AI algorithm has one. Performance is established through validation studies.
How the ground truth for the training set was established: Not mentioned.

In summary, the provided FDA 510(k) clearance letter confirms the regulatory status of the device but does not contain the detailed technical and scientific performance data or study design information you are looking for. To find such information, one would typically need to consult the device's Instructions For Use (IFU), peer-reviewed publications by the manufacturer, or the more detailed (and often redacted) 510(k) summary filed with the FDA, if available, though even that rarely contains all the detail requested.

Summary

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JUN 18 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

K990581 Re:

Trade Name: K-Assay Direct HDL-Cholesterol Reagent K-Assay Direct HDL-Cholesterol Calibrator Regulatory Class: I reserved (Cholesterol Reagent) II (Cholesterol Calibrator) Product Code: LBS, JIS Dated: June 7, 1999 Received: June 11, 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 vour 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/cdrlv/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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): _ K 990581 _________________________________________________________________________________________________________________________________________

K-ASSAY Direct HDL-Cholesterol reagent and calibrator. Device Name:

Indications For Use:

The K-ASSAY Direct HDL-Cholesterol calibrator is intended to be used for the calibration of the K-ASSAY Direct HDL-Cholesterol assay.

(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)
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Over-The-Counter Use
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Optional Format 1-2-96)Direct HDL-Cholesterol Reagent and Calibrator 510(k)

6/07/99

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.