OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH by OLYMPUS AMERICA, INC.

Olympus System Reagent and calibrators for the quantitative determination of C-Reactive Protein in human serum and plasma on OLYMPUS Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk of future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, maybe useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (IVD) called "Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators." This type of device is a reagent system used in laboratory settings to measure C-Reactive Protein (CRP) in human serum and plasma.

The request asks for information about acceptance criteria, device performance, and study details typically associated with AI/ML-driven medical devices, especially those interpreting images or signals. However, this document describes a chemical reagent and not an AI/ML or image analysis device. Therefore, most of the requested information (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of IVD and will not be found in the provided text.

The document discusses the regulatory clearance process for a common laboratory test kit, where "performance" relates to its analytical accuracy and precision in measuring a biomarker, not interpretive accuracy of AI.

I will address the applicable parts of your request based on the provided text, and explicitly state when information is not available or not relevant for this type of device.

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

The provided document (an FDA clearance letter) does not explicitly state the specific acceptance criteria or detailed performance data (like sensitivity, specificity, accuracy, precision, linearity ranges) for the Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators. Such data would typically be found in the 510(k) submission itself, which is not provided here, or in the device's labeling/instructions for use.

The letter merely states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is based on the data presented in the 510(k) submission, confirming the device performs as intended and is as safe and effective as a predicate device.

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

Not applicable / Not provided. The document is an FDA clearance letter for a chemical reagent. It does not contain information about sample sizes for test sets, data provenance, or study design (retrospective/prospective) for performance evaluation. These details would be in the full 510(k) submission.

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)

Not applicable / Not provided. This information is relevant for devices that require human interpretation or expert labeling (e.g., imaging devices). For a CRP reagent, the "ground truth" would be established by reference methods or validated laboratory measurements of CRP, not by expert consensus in the typical sense for image or signal interpretation.

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

Not applicable / Not provided. Adjudication methods are typically used for establishing ground truth in expert-based assessments (e.g., image interpretation). This is not relevant for a chemical reagent's performance evaluation.

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

Not applicable / Not provided. MRMC studies are used for evaluating diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images), often with AI assistance. This device is a chemical reagent, not an AI-driven image analysis or diagnostic interpretation tool.

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

Not applicable / Not provided. This relates to AI algorithms. The Olympus CRP device is a reagent system, not an algorithm. Its performance is inherent to the chemical reactions and measurement principles.

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

Not applicable / Not provided in detail. For a chemical reagent like this, the "ground truth" for evaluating its performance (e.g., accuracy, precision) would typically be reference methods or highly validated laboratory measurements of CRP in clinical samples. The document does not specify the exact methods used for establishing this ground truth.

8. The sample size for the training set

Not applicable / Not provided. The concept of a "training set" doesn't apply to a chemical reagent device in the way it does for AI/ML algorithms.

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

Not applicable / Not provided. See explanation for #8.

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 with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 2 2005

Ms. Bev Harding RA Analyst Olympus America Inc. 3131 West Royal Lane Irving, Texas 75063-3104

Re: K051564

Trade/Device Name: Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: NQD, JIT Dated: June 13, 2005 Received: June 14, 2005

Dear Ms. Harding:

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) I ms letter will anow you to ough mating of substantial equivalence of your device to a legally premarked 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, rr you destre spothing michiance as betising of your device, please contact the Office of In or quotions on c. Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Tou may other 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/industry/support/index.html.

Sincerely yours,

Carol C. Benson

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Olympus CRP Latex Immunoturbidimetric Reagent and Device Name: Calibrators

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

CAC
(Division Sign/Off)

Division of Clinical Laboratory Devices 510(k) Number

Regulation Number and Section

§ 866.5270 C-reactive protein immunological test system.

(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).