RDI DIRECT LDL CHOLESTEROL TEST

• K Number: K984107
• Device Name: RDI DIRECT LDL CHOLESTEROL TEST
• Manufacturer: REFERENCE DIAGNOSTICS, INC.
• Date Cleared: 1999-01-28 ( 72 days)
• Product Code: MRR
• Regulation Number: 862.1475
• Type: Traditional
• Panel: Clinical Chemistry
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

For use in clinical laboratories and physicians' office laboratories for quantitative determination of low density lipoprotein (LDL) cholesterol in human serum as a risk factor in coronary artery disease.

Device Description

Not Found

AI/ML Overview

This is an FDA Premarket Notification (510(k)) for the RDI Direct LDL Reagent (also referred to as RDI Direct LDL Cholesterol Test). This document confirms substantial equivalence to a predicate device and permits marketing. It does not contain information about acceptance criteria or specific study results that prove the device meets such criteria because 510(k) submissions typically rely on comparison to existing predicate devices rather than novel performance studies outlining acceptance criteria for a new type of device.

Therefore, most of the requested information cannot be found in the provided text.

Here's a breakdown of what can and cannot be answered based on the input:

1. A table of acceptance criteria and the reported device performance

• Cannot be answered from the provided text. The document is an FDA letter granting substantial equivalence, not a performance study report.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be answered from the provided text. The document does not describe a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Cannot be answered from the provided text. The document does not describe a clinical study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Cannot be answered from the provided text. The document does not describe a clinical study.

5. 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

• Cannot be answered from the provided text. This device is a reagent for measuring LDL cholesterol, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Cannot be answered from the provided text. This device is a reagent, not an algorithm. Performance of the reagent itself would typically be evaluated without human-in-the-loop unless it's an interpretation step, but the document doesn't provide such details.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Cannot be answered from the provided text. The document does not describe a clinical study. For a diagnostic reagent, ground truth would typically be established by a reference method for the analyte being measured.

8. The sample size for the training set

• Cannot be answered from the provided text. The document does not describe a clinical study or an algorithm requiring a training set.

9. How the ground truth for the training set was established

• Cannot be answered from the provided text. The document does not describe a clinical study or an algorithm requiring a training set.

Summary

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JAN 28 1999

Joseph Lawlor, Ph.D. President Reference Diagnostics, Inc. 23 Crosby Drive Bedford, Massachusetts 01730-1401

K984107 Re: Trade Name: RDI Direct LDL Reagent Regulatory Class: I Product Code: MRR Dated: November 16, 1998 Received: November 17, 1998

Dear Dr. Lawlor:

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.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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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 [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 [phone], 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

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510(k) Number (if known): K984107

Device Name: RDI Direct LDL Cholesterol Test

Indications For Use:

For use in clinical laboratories and physicians' office laboratories for quantitative determination of low density lipoprotein (LDL) cholesterol in human serum as a risk factor in coronary artery disease.

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510(k) Number K984/07

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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.