CHOLESTEROL RAPID LIQUID REAGENT

• K Number: K972853
• Device Name: CHOLESTEROL RAPID LIQUID REAGENT
• Manufacturer: REAGENTS APPLICATIONS, INC.
• Date Cleared: 1997-09-24 ( 89 days)
• Product Code: CHH
• Regulation Number: 862.1175
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

This reagent is intended for the rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers. The determination of serum plasma is one of the important tools in the diagnosis and classification of lipemia. Other conditions, such as hepatic and thyroid diseases, influence cholesterol levels.

Device Description

Cholestero! Rapid |Liquid Reagent

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called "RAICHEM Cholesterol Rapid Liquid Reagent." It does not contain information about the acceptance criteria or a study proving the device meets those criteria in the format requested.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• States that the device can be marketed subject to general controls of the Federal Food, Drug, and Cosmetic Act.
• Provides information about applicable regulations and contact details for further inquiries.

The "Indications for Use" section (page 2 of the document) describes what the reagent is intended for: "rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers." It also mentions that cholesterol determination is important for diagnosing and classifying lipemia and that other conditions influence cholesterol levels.

However, the document does not include any of the following requested information:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information on a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How the ground truth for the training set was established.

Therefore,Based on the provided text, I cannot provide the requested information regarding the acceptance criteria and the study proving the device meets them. The document is an FDA 510(k) clearance letter and details the regulatory approval but does not include the specifics of performance studies or acceptance criteria.

Summary

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SEP 2 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Daniel C. Weyker Vice President RAICHEM Division of Hemagen Diagnostics 8225 Mercury Count San Diego, California 92111-1203

Re: K972853 Trade Name: RAICHEM Cholesterol Rapid Liquid Reagent Regulatory Class: I Product Code: CHH Dated: September 17, 1997 September 24, 1997 Received:

Dear Mr. Weyker:

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 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 aqainst 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 requlations 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 requirement, 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 Reqister. 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 (CDIA-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 at [phone] or at its internet address "http://www.fda.gov/cdrh/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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510(k) Number: K972853

Device Name: Cholestero! Rapid |Liquid Reagent

Indications for Use:

This reagent is intended for the rapid quantitative in-vitro measurement of total serum or plasma cholesterol concentration, utilizing manual or automated analyzers. The determination of serum plasma is one of the important tools in the diagnosis and classification of lipemia. Other conditions, such as hepatic and thyroid diseases, influence cholesterol levels.

V. Lucille Chamber, Ph.D.

prescription us

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Regulation Number and Section

§ 862.1175 Cholesterol (total) test system.

(a)
Identification. A cholesterol (total) test system is a device intended to measure cholesterol in plasma and serum. Cholesterol measurements are used in the diagnosis and treatment of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders.(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.