Chymofast Test

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

510(k) Number

K833418 ↗

FDA Product Code

DHB

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Total Ige Fast Test

  Class II

  FDA 510(k) K834594 Active Cleared 10 Feb 1984

• Allergenetics Ige Fast Test

  Class II

  FDA 510(k) K851512 Active Cleared 28 May 1985

• Allergenetics Ige-Fast Test

  Class II

  FDA 510(k) K822341 Active Cleared 10 Nov 1982

• Theofast Test Kit for Quantitative Theo

  Class II

  FDA 510(k) K834244 Active Cleared 24 Jan 1984

• Allergenetics Aller-Specific Ige Serum

  Class II

  FDA 510(k) K842969 Active Cleared 28 Aug 1984

• Allergentics Total Ige/Theophylline

  Class I

  FDA 510(k) K842970 Active Cleared 29 Aug 1984

See all devices from Allergenetics →

• What clinical specialty is the Chymofast Test primarily used in, and how does that influence its application in a lab setting?

  The Chymofast Test is designed for use in immunology diagnostics, specifically to measure allergen-specific IgE antibodies in human serum. This focus makes it ideal for clinical laboratories assessing allergic conditions, such as asthma, hay fever, or food allergies. Its classification under FDA regulation 866.5750 (Radioallergosorbent Test Systems) and advisory committee designation for Immunology ensures it aligns with specialty standards for accurate allergen testing.

• Is the Chymofast Test intended for single-use, and if so, what does this mean for lab workflows?

  Yes, the Chymofast Test is intended for single-use only, as explicitly stated in its regulatory documentation. This means each kit is designed for one diagnostic procedure, reducing cross-contamination risks and ensuring consistent, reliable results. Labs must account for this in their workflows by ordering replacement kits for each test and adhering to proper disposal protocols for used components.

• What storage and handling requirements should a lab follow to maintain the accuracy of the Chymofast Test?

  While the exact storage conditions aren’t detailed in the provided data, the Chymofast Test’s single-use nature and sensitivity as an immunological diagnostic imply it requires careful handling per the manufacturer’s instructions. Typically, such tests need protection from extreme temperatures, light exposure, and contamination. Labs should store the kit in its original packaging, away from direct sunlight or moisture, and follow the accompanying documentation to preserve sterility and performance until use.

• How does the Chymofast Test’s regulatory pathway (e.g., FDA clearance) affect its adoption or integration into a lab’s diagnostic menu?

  The Chymofast Test holds an FDA 510(k) clearance (K833418) with a Substantially Equivalent (SESE) designation, granted in 1984, under the Radioallergosorbent Test System classification. This clearance confirms it meets FDA standards for safety and effectiveness as a Class II device, which can reassure labs of its regulatory compliance. However, since it’s an older clearance, labs should verify compatibility with current laboratory practices and confirm any updates from Allergenetics regarding usage or alternatives, as medical device standards may evolve.