Scrippsera ANA Reference Control Sera

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

510(k) Number

K810081 ↗

FDA Product Code

DHN

Device Class

Class II

Regulation

21 CFR Part 866.5100

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Hep-2-Crithidia Luciliae Ana Test Kit

  Class II

  FDA 510(k) K811714 Active Cleared 10 Jul 1981

• 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

See all devices from Scripps-Miles, Inc. →

• What is the Scrippsera ANA Reference Control Sera used for?

  The Scrippsera ANA Reference Control Sera serves as a standardized reference control for validating and calibrating indirect immunofluorescence assays used to detect antinuclear antibodies (ANA) in clinical immunology testing. It helps laboratories maintain accuracy and reliability in diagnostic procedures by providing a consistent benchmark for comparison.

• How is the Scrippsera ANA Reference Control Sera supplied and stored?

  The product is supplied as a liquid in a single-use format, designed for laboratory use only. It does not require specialized storage conditions beyond standard refrigeration to preserve its integrity and performance.

• Is the Scrippsera ANA Reference Control Sera intended for direct patient use?

  No, this device is explicitly not intended for direct administration to patients. Instead, it functions solely as a quality control measure in serological testing, ensuring the accuracy of immunofluorescent assays for ANA detection in laboratory settings.

• What regulatory pathway does the Scrippsera ANA Reference Control Sera follow?

  The Scrippsera ANA Reference Control Sera was cleared through the FDA’s 510(k) process (K810081) in 1981 under product code DHN, classified as substantially equivalent (SESE) by the Immunology (IM) Advisory Committee. It is regulated under FDA regulation 866.5100 and is categorized as a Class II medical device.

• Can this control be reused after opening?

  The Scrippsera ANA Reference Control Sera is designed for single-use only. Reusing it could compromise the accuracy of assay validation and quality control, as it is intended to provide a consistent baseline for each test run without contamination or degradation.