Autostat II Anti-Sm/RNP Elisa

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

510(k) Number

K990624 ↗

FDA Product Code

LKO

FDA applicant

Cogent Diagnotics , Ltd.

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Autostat Antithyroglobin

  Class II

  FDA 510(k) K925784 Active Cleared 21 Jan 1993

• Autostat(Tm) Anti-Dsna

  Class II

  FDA 510(k) K913342 Active Cleared 1 May 1992

• Autostat Anti-Thyroglobulin

  Class II

  FDA 510(k) K923370 Active Cleared 22 Sep 1992

• Autostat II Anti-Ss-a/Ro Elisa

  Class II

  FDA 510(k) K990627 Active Cleared 28 Apr 1999

• Autostat II ANA Screen ELISA

  Class II

  FDA 510(k) K983655 Active Cleared 28 Jan 1999

• Autostat II Anti-Cardiolipin Screen Elisa

  Class II

  FDA 510(k) K993085 Active Cleared 1 Feb 2000

See all devices from Cogent Diagnotics, Ltd. →

• What is the primary clinical purpose of the Autostat II Anti-Sm/RNP ELISA?

  This device is an in vitro diagnostic test designed to detect anti-Sm and anti-RNP antibodies in human serum samples. It is specifically intended to aid laboratory professionals in the diagnosis of autoimmune diseases, with a focus on Mixed Connective Tissue Disease.

• Who is the intended user for this diagnostic test?

  The Autostat II Anti-Sm/RNP ELISA is intended for use by laboratory professionals within clinical settings. It requires professional handling to perform the enzyme-linked immunosorbent assay technology correctly and interpret the results.

• What is the regulatory status of this device?

  The Autostat II Anti-Sm/RNP ELISA is a Class 2 immunology device that has received FDA 510(k) clearance under the traditional pathway, identified by the K990624 submission.