Hep-2-Crithidia Luciliae Ana Test Kit

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

510(k) Number

K811714 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Scrippsera Theumatoid Factor Refer. Cntl

  Class II

  FDA 510(k) K810221 Active Cleared 9 Feb 1981

• Scrippsera Complement Control Sera

  Class I

  FDA 510(k) K811433 Active Cleared 16 Jun 1981

• Scrippsystem C4 Rid Kit

  Class II

  FDA 510(k) K810502 Active Cleared 8 Apr 1981

• Scrippsystem C3 Rid Kit

  Class II

  FDA 510(k) K810501 Active Cleared 8 Apr 1981

• Scrippsystem Nephelometric Antisera Kit

  Class II

  FDA 510(k) K812328 Active Cleared 8 Sep 1981

• Scrippsera ANA Reference Control Sera

  Class II

  FDA 510(k) K810081 Active Cleared 9 Feb 1981

See all devices from Scripps-Miles, Inc. →

• What types of autoimmune diseases can this test help identify when detecting antinuclear antibodies (ANA) using Crithidia luciliae cells?

  This test uses Crithidia luciliae cells to detect specific immunofluorescence patterns linked to autoimmune diseases, particularly systemic lupus erythematosus (SLE). It can also help identify other connective tissue disorders where ANA presence is relevant, though the exact disease correlation depends on clinical interpretation of the pattern observed.

• Is this test kit single-use, and if so, what are the storage requirements?

  Yes, the HEP-2 Crithidia Luciliae ANA Test Kit is designed for single-use only. Storage is straightforward—no special conditions are required beyond refrigeration, ensuring stability and reliability for diagnostic use.

• How is this device regulated, and what pathway was used for its FDA clearance?

  This device is classified as a Class II medical device under FDA regulation number 866.5100 and was cleared via the Traditional 510(k) pathway in 1981. It adheres to immunology testing standards and is intended for use in clinical laboratories performing indirect immunofluorescence assays.

• What kind of samples can be tested with this kit, and is it compatible with any imaging modalities?

  The kit is designed for in vitro diagnostic use with serum or plasma samples. It is not MRI-compatible, so it cannot be used in magnetic resonance imaging environments.