DS-DNA EIA Diagnostic Kit

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

510(k) Number

K870453 ↗

FDA Product Code

LJM

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Rnp Eia Diagnostic Kit

  Class II

  FDA 510(k) K870457 Active Cleared 17 Mar 1987

• SS-DNA EIA Diagnostic Kit

  Class II

  FDA 510(k) K870452 Active Cleared 17 Mar 1987

• Histones Eia Diagnostic Kit

  Class II

  FDA 510(k) K870458 Active Cleared 17 Mar 1987

• Dnp Eia Diagnostic Kit

  Class II

  FDA 510(k) K870456 Active Cleared 17 Mar 1987

• Ana-Enzyme Immunoassay (Ana-Eia) Diagnostic Kit

  Class II

  FDA 510(k) K862969 Active Cleared 24 Oct 1986

• Sm Eia Diagnostic Kit

  Class II

  FDA 510(k) K870455 Active Cleared 17 Mar 1987

• What is the DS-DNA EIA Diagnostic Kit used for?

  The DS-DNA EIA Diagnostic Kit is an enzyme immunoassay device used for the detection of double-stranded DNA (dsDNA) antibodies. It is classified as an antinuclear antibody test and is intended for use in immunology testing for in vitro diagnostic purposes.

• How is the DS-DNA EIA Diagnostic Kit supplied and what is its intended use?

  The device is supplied as a diagnostic kit and is intended for in vitro diagnostic use. It is designed for laboratory testing to detect dsDNA antibodies in patient samples as part of immunology assessments.

• What regulatory pathway was used for the DS-DNA EIA Diagnostic Kit and what is its classification?

  The DS-DNA EIA Diagnostic Kit received FDA 510(k) clearance (K870453) on March 24, 1987, through a traditional submission. It is regulated as a Class II medical device under regulation number 866.5100 with product code LJM.

• What does the FDA 510(k) clearance K870453 indicate about the DS-DNA EIA Diagnostic Kit?

  The FDA 510(k) clearance K870453 indicates that the DS-DNA EIA Diagnostic Kit was found substantially equivalent to a legally marketed predicate device. The decision description is 'Substantially Equivalent' and it was cleared via a traditional 510(k) pathway.

• Is the DS-DNA EIA Diagnostic Kit intended for reuse or single-use applications?

  The device data does not specify whether the DS-DNA EIA Diagnostic Kit is intended for single-use or reuse. As a diagnostic kit containing reagents and controls, it is typically designed for single-use testing runs, but reuse characteristics must be determined from the product labeling or manufacturer’s instructions, which are not provided in the data.