Sensi-Slide

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

510(k) Number

K792657 ↗

FDA Product Code

JHJ

Device Class

Class II

Regulation

21 CFR Part 862.1155

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Cobas Reagent for Calcium

  Class II

  FDA 510(k) K823577 Active Cleared 7 Jan 1983

• Test, in-Vitro Diagnostic

  Not classified

  FDA 510(k) K760089 Active Cleared 20 Jul 1976

• Hcg Radioimmunoassay

  Class II

  FDA 510(k) K811116 Active Cleared 13 May 1981

• Cobas Creatinine Standards

  Class II

  FDA 510(k) K823572 Active Cleared 7 Jan 1983

• Sensi-Tex

  Class II

  FDA 510(k) K790267 Active Cleared 21 Mar 1979

• Abuscreen Radioimmunoassay - Amphetamine

  Class II

  FDA 510(k) K823212 Active Cleared 29 Nov 1982

See all devices from Hoffmann-La Roche, Inc. →

• What is the Sensi-Slide used for in clinical settings?

  The Sensi-Slide is designed for the qualitative detection of human chorionic gonadotropin (hCG) in clinical chemistry applications. It employs an agglutination method, where the presence of hCG in a sample causes visible clumping of particles, allowing for straightforward visual interpretation of test results. This makes it useful for confirming pregnancy or monitoring hCG levels in laboratory environments.

• How is the Sensi-Slide supplied and stored?

  The Sensi-Slide is supplied as a single-use diagnostic tool intended for in vitro testing. It does not require special storage conditions beyond those standard for clinical chemistry reagents. Always follow laboratory protocols for handling diagnostic substrates to ensure accuracy and safety.

• Is the Sensi-Slide reusable or MRI-safe?

  No, the Sensi-Slide is not designed for reuse. It is a single-use device intended for one-time clinical testing. Additionally, it is not MRI-safe, meaning it should not be used or stored in an MRI environment.

• What regulatory approval does the Sensi-Slide have?

  The Sensi-Slide has received FDA 510(k) clearance under product code JHJ, with a decision of Substantially Equivalent by the Clinical Chemistry Advisory Committee. This clearance confirms its compliance with FDA regulations for diagnostic substrates and reagents under classification 862.1155.

• Can the Sensi-Slide be used outside of laboratory settings?

  The Sensi-Slide is specifically intended for use in laboratory settings. Its design and validation align with clinical chemistry protocols, which typically require controlled environments to ensure accurate and reliable test results.