OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 by OLYMPUS AMERICA, INC.

Measurements of Uric Acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Device Description

Not Found

AI/ML Overview

The provided text focuses on the FDA's 510(k) clearance of the Olympus Uric Acid Reagent, establishing its substantial equivalence to a predicate device. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.

Therefore, I cannot populate the table or provide specific answers to most of your questions based solely on the provided text. The document is a regulatory clearance letter, not a scientific study report.

Here's what I can extract and what is missing:

Information Present:

Device Name: Olympus Uric Acid Reagent
Intended Use: Quantitative determination of Uric Acid in human serum, heparinized plasma, and urine on OLYMPUS analyzers.
Clinical Utility: Used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and patients receiving cytotoxic drugs.
Regulatory Clearance: 510(k) clearance (K062862) issued on April 6, 2007.

Information NOT Present (and why it's typically in a study report, not a clearance letter):

Acceptance Criteria and Reported Device Performance Table: The document doesn't list specific performance metrics (like accuracy, precision, linearity, limits of detection) or the thresholds for acceptable performance. It only states the device is substantially equivalent, implying its performance is comparable to an existing device.
Sample Size for Test Set and Data Provenance: This information would be detailed in a validation study report.
Number of Experts and Qualifications: Not relevant for a chemistry reagent validation; typically for image-based diagnostics where human interpretation is involved.
Adjudication Method: Not relevant for a chemistry reagent.
MRMC Comparative Effectiveness Study: Not relevant for a chemistry reagent. This applies to diagnostic tools where human interpretation is augmented by AI.
Standalone Performance: While the "device" (reagent) performs standalone, the document doesn't provide the specific performance data.
Type of Ground Truth Used: For a chemistry assay, the ground truth would typically be established using a reference method or certified reference materials with known uric acid concentrations. The document doesn't specify this.
Sample Size for Training Set: Not applicable in the context of a chemical reagent validation in the same way it would be for a machine learning model.
How Ground Truth for Training Set was Established: Again, not applicable as there's no "training set" in the machine learning sense for this type of device.

Conclusion:

The provided document is a regulatory approval letter. While it confirms the device's market readiness and intended use, it does not contain the detailed technical specifications or study results required to answer your specific questions about acceptance criteria and performance study design. This information would typically be found in the 510(k) submission summary or a separate validation study report, which is not included here.

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 features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Olympus America, Inc., c/o Ms. Bev Harding 3131 West Royal Lane Irving, TX 75063-3104

APR - 6 2007

Re: K062862 Trade Name: Olympus Uric Acid Reagent Regulation Number: 21 CFR §862.1775 Regulation Name: Uric acid test system. Regulatory Class: Class I (Reserved) Product Code: KNK Dated: February 21, 2007 Received: February 22, 2007

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) 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 (240) 276-0490. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. 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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Olympus Uric Acid Premarket Notification

Indications for Use

510(k) Number (if known):

Device Name:

Olympus Uric Acid Reagent

Indications for Use:

System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

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

Carol Benam

ion Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

062862

Regulation Number and Section

§ 862.1775 Uric acid test system.

(a)
Identification. A uric acid test system is a device intended to measure uric acid in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.(b)
Classification. Class I (general controls). The device, when it is solely intended for use as an acid reduction of ferric ion test, a phosphotungstate reduction test, a gasometric uricase test, an ultraviolet uricase test, or an oxygen rate uricase test, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.