Raichem Cholesterol Rapid Liquid Reagent may be used with the CANTROL® HDL Cholesterol Precipitating Reagent Tubes to separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease. For In Vitro Diagnostic Use Only.

Device Description

Not Found

AI/ML Overview

This is a 510(k) premarket notification for a Class I in vitro diagnostic device, not an AI/ML medical device. Therefore, the questions related to AI/ML device studies, such as acceptance criteria, sample sizes for test/training sets, expert involvement, and ground truth establishment, are not applicable.

The document indicates that the device, "Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer," has been determined to be substantially equivalent to legally marketed predicate devices. This means that the FDA has agreed that the device is as safe and effective as a device already on the market.

Here's a breakdown of the relevant information provided for this specific submission:

A table of acceptance criteria and the reported device performance:
Not applicable in this document. Substantial equivalence for this type of device typically relies on demonstrating comparable performance to a predicate device, as opposed to meeting pre-defined acceptance criteria for novel AI/ML performance metrics.
Sample size used for the test set and the data provenance:
Not applicable in this document. This submission does not detail a clinical study with a "test set" in the context of AI/ML validation data. Performance is likely demonstrated through analytical studies (e.g., accuracy, precision, linearity) comparing the device to a predicate, not through a prospective clinical study using a specified patient sample size.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The concept of "ground truth" established by experts for a diagnostic algorithm is not relevant for this Class I lipoprotein test system.
Adjudication method for the test set:
Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is an in vitro diagnostic assay, not an AI-powered diagnostic imaging or interpretation tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable.
The type of ground truth used:
Not applicable. The performance of this device would be evaluated against established analytical methods and reference standards for HDL cholesterol measurement, not against an "expert consensus" or "pathology" ground truth as understood in AI/ML validation.
The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
How the ground truth for the training set was established:
Not applicable.

Summary of the K023784 Submission:

Device Name: Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer
Indication(s) For Use: To separate and determine HDL cholesterol in serum or EDTA plasma on the Cobas Mira chemistry systems. High-density lipoprotein measurement in conjunction with other lipid determinations has been shown to be useful in assessing the risk of coronary artery disease.
Regulatory Class: Class I
Product Code: LBR (Lipoprotein test system)
Decision: Substantial Equivalence to legally marketed predicate devices.
Date: December 10, 2002

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Public Health Service

ood and Drug Administr. 2098 Gaither Boad Rockville MD 20850

Mr. Jose A. Montanez Corporate Director, OA/RA Official Correspondent Raichem Div. of Hemagen® Diagnostics, Inc. 9033 Red Branch Road Columbia, MD 21045

K023784 Re:

Trade/Device Name: Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira AnayIzer

Regulation Number: 21 CFR 862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I Product Code: LBR Dated: December 10, 2002 Received: December 12, 2002

Dear Mr. Montanez:

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 (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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 Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Device Name:

Raichem HDL Cholesterol using Cantrol HDL Precipitating Tubes on the Cobas Mira Analyzer

Indication(s) For Use

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Alan Cooper

(Division Sign-Off)
Division of Clinical Laborato

510(k) Number K023784

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use_

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.