OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CALIBRATOR, OLYMPUS HDL/LDL CHOLESTEROL CONTROL SERA by OLYMPUS AMERICA, INC.

The Olympus LDL Cholesterol Test System contains LDL Cholesterol Reagent, LDL Cholesterol Calibrator, and Assayed HDL/L/L/L Cholesterol Control materials intended for use on the Olympus Family of Clinical Chemistry Analyzers for the quantitative determination of LDL Cholesterol concentrations in human serum and plasma.

The Olympus LDL Cholesterol Calibrator is a lyophilized human serum intended to provide an LDL concentration of known value for use in calibration of the Olympus LDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.

The Olympus HDL/LDL Cholesterol Control consists of lyophilized human sera. These assayed control sera a designed to monitor the recovery and precision of the Olympus LDL Cholesterol Reagent used on the Olympus family of Clinical Chemistry Analyzers.

LDL Cholesterol levels play a causal role in the development of coronary artery disease and is used for the measurement of the LDL Cholesterol concentration in serum and plasma.

Device Description

Not Found

AI/ML Overview

This FDA 510(k) clearance document for the Olympus LDL Cholesterol Test System does not contain the detailed information required to fill out the table and answer all the questions about acceptance criteria and the study proving device performance as it pertains to an AI/ML device.

This document is for an in vitro diagnostic device (a chemistry analyzer for determining LDL Cholesterol levels), not an AI/ML device. Therefore, many of the questions regarding AI-specific evaluation metrics (like expert readers, adjudication, MRMC studies, training sets, etc.) are not applicable here.

However, I can extract information relevant to the type of device and its intended use, which might be analogous to what would be expected for a diagnostic device.

Here's what I can provide based on the given document:

Device Type: In Vitro Diagnostic (IVD) - Specifically, a Lipoprotein Test System and Calibrator for quantitative determination of LDL Cholesterol.

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

The document does not explicitly state specific acceptance criteria or reported performance metrics in a tabular format. For IVD devices like this, typical performance metrics would include:

Accuracy/Bias: Comparison to a reference method (e.g., CDC reference method for cholesterol).
Precision/Reproducibility: Within-run, between-run, and total precision (CV% or SD).
Linearity/Measuring Range: The range over which the device accurately measures concentrations.
Interference: Lack of significant interference from common substances in serum/plasma.
Stability: Reagent and calibrator stability.
Method Comparison: Correlation and agreement with a predicate device.

Since these specific details are not in the provided clearance letter, I cannot populate a table.

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

This information is not provided in the FDA clearance letter. The letter explicitly states that the device is "substantially equivalent" to predicate devices, implying that the manufacturer submitted data, but the specifics of the study design (sample size, data provenance) are not part of this summary document.

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)

This is not applicable in the context of an IVD device for quantitative chemical measurement. Ground truth for chemical analytes is typically established by certified reference materials or highly accurate reference methods, not by expert human interpretation in the way it is for image-based diagnostics.

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

This is not applicable for a quantitative IVD device. Adjudication methods are typically used for qualitative or expert-interpreted diagnostic tasks (e.g., radiology, pathology).

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

This is not applicable as this is not an AI-assisted diagnostic device.

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

This is not applicable as this is an automated chemistry analyzer, not an AI algorithm. Its performance is inherently "standalone" in the sense that it provides a quantitative result without human subjective interpretation of the primary measurement.

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

For a quantitative IVD device like this, the ground truth would typically be established by reference methods or certified reference materials (e.g., from organizations like the CDC or NIST) for LDL Cholesterol, rather than expert consensus, pathology, or outcomes data. The document does not specify which reference method was used.

8. The sample size for the training set

This information is not provided and is not typically relevant for the type of IVD device described. While a manufacturer would develop and validate the reagent and analyzer, the concept of a "training set" in the machine learning sense does not apply directly to this chemistry-based measurement system.

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

This is not applicable for the reasons stated above.

Summary

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 0 8 2002

Mr. Michael Campbell Manager, Regulatory Affairs/Quality Assurance Olympus America Inc Diagnostic Systems Group 3131 West Royal Lane Irving Texas 75063-3104

Re: K014032

Trade/Device Name: Olympus LDL Cholesterol Test System Regulation Number: 21 CFR 862.1475; 21 CFR 862.1150 Regulation Name: Lipoprotein test system; Calibrator Regulatory Class: Class I; Class II Product Code: LBS; JIT Dated: January 18, 2002 Received: January 22, 2002

Dear Mr. Campbell:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 i 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" (21CFR 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/odrb/dsma/dsmamain.html".

Sincerely yours,

Steven Butman

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): K014032

Device Name:

Olympus LDL Cholesterol Test System Contents: Olympus LDL Cholesterol Reagent Olympus LDL Cholesterol Calibrator Olympus HDL/LDL Cholesterol Control

Indications for Use:

(per 21 CFR 801.109)

LDL Cholesterol levels play a causal role in the development of coronary artery disease and is used for the measurement of the LDL Cholesterol concentration in serum and plasma.

Sean Ciofin

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K014632

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use	OR Over-The-Counter Use
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(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.