Affinity HTSH Immunit

No FDA recalls on record, checked 22 Oct 2026.

Full name

Affinity(Tm) Htsh Immunit(Tm)

510(k) Number

K865081 ↗

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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See all devices from Bd Becton Dickinson Vacutainer Systems Preanalytic →

• What is the purpose of the Affinity HTSH Immunit device?

  The Affinity HTSH Immunit is a radioimmunoassay device designed to quantify thyroid-stimulating hormone (TSH) in clinical specimens. It utilizes immunological binding principles to provide a measurable signal proportional to the concentration of TSH in the sample.

• How is the Affinity HTSH Immunit device supplied?

  The device is supplied by Becton Dickinson Vacutainer Systems Preanalytic for use in clinical chemistry laboratories. It is classified as a Class 2 Chemistry device (product code JLW) and received traditional 510(k) clearance (K865081) as substantially equivalent on March 12, 1987.

• What regulatory pathway does the Affinity HTSH Immunit follow?

  The device follows the FDA 510(k) regulatory pathway and received traditional 510(k) clearance (K865081) as substantially equivalent on March 12, 1987. It is classified as a Class 2 Chemistry device (product code JLW) under the advisory committee for Clinical Chemistry.

• What are the key features of the Affinity HTSH Immunit device?

  The device is designed to quantify thyroid-stimulating hormone in clinical specimens using immunological binding principles. It provides a measurable signal proportional to the concentration of TSH in the sample, making it suitable for clinical chemistry laboratory use.