Rheumelisa Assay for Ss-B/La Autoantibodies

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K895995 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Sm Antibody Test Kit

  Class II

  FDA 510(k) K880254 Active Cleared 6 Apr 1988

• Access R-Clone Ana Profile Assay

  Class II

  FDA 510(k) K885048 Active Cleared 24 Jan 1989

• La Antibody Test Kit

  Class II

  FDA 510(k) K874195 Active Cleared 11 Mar 1988

• Rheumelisa Assay for Sm Autoantibodies

  Class II

  FDA 510(k) K895996 Active Cleared 6 Nov 1989

• Access R-Clone(Tm) Ana/Rf Screening Assay

  Class II

  FDA 510(k) K882740 Active Cleared 22 Sep 1988

• Lipogen Rheumelisa Dsdna Assay

  Class I

  FDA 510(k) K902636 Active Cleared 28 Jun 1990

See all devices from Lipogen, Inc. →

• What is the RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES used for?

  The RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES is designed for the detection of SS-B/La autoantibodies in human serum, serving as an in vitro diagnostic tool in immunology specialty laboratories to support clinical evaluation of autoimmune conditions.

• How is the RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES supplied and intended for use?

  The device is supplied as a reagent kit for use in clinical laboratory settings and is intended for single-use testing, meaning each test requires a fresh kit component set to ensure accurate and reliable detection of SS-B/La autoantibodies in human serum samples.

• What regulatory pathway was used for the RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES?

  The RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIES received FDA 510(k) clearance under submission number K895995, indicating it was found substantially equivalent to a legally marketed predicate device under regulation 866.5100 for Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls.