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SENSI-TEX

by Hoffmann-La Roche, Inc.

510(k) K790267

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK790267 Date21 Mar 1979ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JHJ
Device Class
Class II
Regulation
21 CFR Part 862.1155
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

SENSI-TEX is an in vitro diagnostic reagent used for determining pregnancy through the agglutination method for human chorionic gonadotropin. This device is classified under clinical chemistry and is designed for laboratory use in medical testing.

SENSI-TEX is supplied as a single-use device and requires appropriate storage conditions. The device received FDA 510(k) clearance with number K790267 on March 21, 1979, and is classified as Class II under regulation number 862.1155. It is manufactured by Hoffmann-La Roche Inc. and is not intended for MRI use.

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Questions

AI-generated answers, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical purpose does SENSI-TEX serve?

    SENSI-TEX is used in laboratory settings to determine pregnancy by detecting human chorionic gonadotropin (hCG) through an agglutination reaction, providing a reliable in‑vitro diagnostic result for clinicians.

  • Is SENSI-TEX supplied as a single‑use or reusable product?

    The reagent is supplied as a single‑use device, meaning each unit is intended for one patient test only and must be discarded after use to maintain accuracy and prevent cross‑contamination.

  • What storage conditions are required for SENSI-TEX?

    SENSI-TEX must be stored according to the manufacturer’s specifications, typically in a controlled environment that protects it from extreme temperatures and moisture, ensuring the reagent remains stable and effective until the expiration date.

  • Under which regulatory pathway was SENSI-TEX cleared?

    SENSI‑TEX received FDA 510(k) clearance (K790267) on March 21, 1979, classified as a Class II device under regulation 862.1155, indicating it met the necessary safety and performance standards for clinical chemistry use.