Autostattmii Anti-Dsdna

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K952567 ↗

FDA Product Code

LRM

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 AutoStat II Anti-DSDNA assay used for?

  The AutoStat II Anti-DSDNA is an enzyme-labeled antibody assay designed for the quantitative detection of antibodies to double-stranded DNA (anti-DSDNA). It is primarily used in clinical settings to assist with the diagnosis or monitoring of autoimmune diseases, such as systemic lupus erythematosus (SLE). By measuring anti-DSDNA levels, clinicians can better evaluate disease activity or progression.

• How is the AutoStat II Anti-DSDNA supplied, and is it single-use?

  The AutoStat II Anti-DSDNA is supplied as a reagent kit intended exclusively for laboratory use. According to the provided data, it is designed for single-use only, meaning each kit should not be reused after opening or testing.

• What regulatory pathway does the AutoStat II Anti-DSDNA follow?

  The AutoStat II Anti-DSDNA is regulated under the FDA’s Traditional 510(k) pathway and has received clearance (K952567) as a Class 2 medical device. This classification and clearance route indicate that the device is deemed substantially equivalent to a predicate device already on the market, ensuring it meets established safety and performance standards for in vitro diagnostic use.

• Does the AutoStat II Anti-DSDNA come with controls, and what role do they play?

  Yes, the AutoStat II Anti-DSDNA kit includes controls as part of its design. Controls are essential for validating the assay’s performance, ensuring accuracy, and confirming that the test is functioning correctly before and during use. They help verify the reliability of results by providing reference values for comparison.

• What immunology specialty does the AutoStat II Anti-DSDNA fall under?

  The AutoStat II Anti-DSDNA is categorized under the immunology specialty, specifically within the classification of enzyme-labeled anti-DNA antibody assays. This classification aligns with its intended use in diagnosing or monitoring autoimmune conditions, where antibody detection plays a critical role in clinical decision-making.