In Vitro Diagnostic Radioimmunoassay

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K813525 ↗

FDA Product Code

JLW

Device Class

Class II

Regulation

21 CFR Part 862.1690

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the In Vitro Diagnostic Radioimmunoassay used for?

  The In Vitro Diagnostic Radioimmunoassay is a laboratory test specifically designed to measure thyroid-stimulating hormone levels in blood samples. It utilizes radioactive tracers to detect and quantify specific hormones with high sensitivity, making it a valuable diagnostic tool for thyroid function assessment.

• How is the In Vitro Diagnostic Radioimmunoassay supplied?

  The device is supplied for laboratory use and is intended for in vitro diagnostic applications only. It is manufactured by Micromedic Systems in McHenry, Illinois, and is regulated under FDA regulation number 862.1690, ensuring proper handling and application in laboratory settings.

• What is the regulatory status of this device?

  The In Vitro Diagnostic Radioimmunoassay received FDA 510(k) clearance on December 31, 1981, with a decision code of SESE, indicating substantial equivalence. It is classified as a Class II medical device under product code JLW, with special controls applied to ensure safety and effectiveness.

• Is this device reusable or single-use?

  The device description does not specify whether the In Vitro Diagnostic Radioimmunoassay is designed for single-use or reuse. As a laboratory test utilizing radioactive tracers, it would typically be used according to laboratory protocols and safety guidelines for handling radioactive materials.