Blastomyces Dermatitidis Antigen (JWW)

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

Full name

Blastomyces Dermatitidis, Antigen

510(k) Number

K792680 ↗

FDA Product Code

JWW

Device Class

Class II

Regulation

21 CFR Part 866.3060

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

• Candida Albicans, Antiserum

  Class II

  FDA 510(k) K792713 Active Cleared 23 Jan 1980

• Lacto-Phenol Analine Blue Fluid

  Class I

  FDA 510(k) K792703 Active Cleared 24 Jan 1980

• Immunocard Mycoplasma

  Class I

  FDA 510(k) K934550 Active Cleared 20 Sep 1994

• Histoplasma Capsulatum, Antiserum

  Class II

  FDA 510(k) K792718 Active Cleared 17 Jan 1980

• Blastomyces Dermatitidis, Antiserum

  Class II

  FDA 510(k) K792685 Active Cleared 17 Jan 1980

• Para-Pak

  Class II

  FDA 510(k) K811377 Active Cleared 16 Jun 1981

See all devices from Meridian Diagnostics, Inc. →

• What types of samples can this test detect *Blastomyces dermatitidis* antigens in, and are there any limitations?

  This test is designed for in vitro use with serum, plasma, or body fluids to detect *Blastomyces dermatitidis* antigens. However, urine specimens require a separate assay, so it is not suitable for direct urine testing without additional processing.

• Is this device intended for single-use or can it be reused?

  The device is classified as a Class 2 diagnostic antigen test, which typically implies single-use for clinical diagnostic purposes. Reuse is not mentioned in the specifications, and reprocessing could compromise accuracy or sterility.

• What regulatory pathway was used to clear this device, and what does that mean for its use?

  This device was cleared via the Traditional 510(k) pathway (K792680) under 21 CFR 866.3060, meaning it was determined to be substantially equivalent to a legally marketed predicate device. This clearance ensures it meets FDA standards for safety and effectiveness as an in vitro diagnostic for detecting *Blastomyces dermatitidis* antigens.

• What medical specialty is this device primarily associated with, and why?

  This device falls under the Microbiology medical specialty category, as it is specifically designed for diagnostic use in identifying *Blastomyces dermatitidis* antigens. This classification aligns with its role in laboratory testing for fungal infections.