House Dust; Hollister-Stier (H/S) Allergen Disc

No FDA recalls found in the data synced 5 Oct 2026.

510(k) Number

K875110 ↗

FDA Product Code

DHB

Models / Variants

House Dust

Hollister-Stier (H/S) Allergen Disc

Device Class

Class II

Regulation

21 CFR Part 866.5750

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Incstar Cytomegalovirus Igm Capture Elisa Assay Model 8530

  Class II

  FDA 510(k) K960434 Active Cleared 17 Oct 1996

• Incstar Epstein-Barr Viral Capsid Antigen (Vca) Lgm Elisa Kit

  Class I

  FDA 510(k) K946157 Active Cleared 7 Jun 1995

• Incstar Epstein-Barr Viral Capsid Antigen (Vca) Igg Elisa Kit

  Class I

  FDA 510(k) K946159 Active Cleared 7 Jun 1995

• Incstar's Birch Allergen Disc

  Class II

  FDA 510(k) K880168 Active Cleared 11 May 1988

• Incstar's Dandelion Allergen Disc

  Class II

  FDA 510(k) K880187 Active Cleared 21 Apr 1988

• BETA2 M-Trac by Enzyme Bead-Based Immunoassay Eia

  Class II

  FDA 510(k) K895496 Active Cleared 17 Oct 1989

See all devices from Incstar Corp. →

• What is the Hollister-Stier House Dust Allergen Disc used for?

  This allergen disc is designed for in vitro allergy testing using Radioallergosorbent Testing (RAST). It provides a standardized source of house dust allergens to detect and quantify IgE antibodies in patient samples, helping clinicians diagnose allergies to house dust mites. It is intended for use in clinical immunology laboratories following standard laboratory protocols.

• How is the Hollister-Stier House Dust Allergen Disc supplied and intended for use?

  The disc is supplied as a single-use diagnostic reagent, meaning each disc is intended for one-time use in a single RAST test. This ensures sterility and consistency in testing results. It is regulated as a Class II medical device under FDA 510(k) clearance (K875110) and adheres to standard sterile diagnostic reagent handling guidelines for clinical immunology labs.

• Is the Hollister-Stier House Dust Allergen Disc sterile and how should it be stored?

  As a single-use diagnostic reagent, the Hollister-Stier House Dust Allergen Disc is intended to be sterile for its intended use. Storage should follow typical guidelines for sterile diagnostic reagents, which generally include keeping it in a clean, dry environment, protected from light, and at room temperature unless otherwise specified by the manufacturer. Always refer to the accompanying instructions for precise storage instructions.

• What regulatory pathway does the Hollister-Stier House Dust Allergen Disc follow?

  The Hollister-Stier House Dust Allergen Disc is classified under FDA regulation 866.5750 as a System, Test, Radioallergosorbent (RAST) Immunological device. It has received FDA 510(k) clearance (K875110) and is categorized as a Class II medical device. This clearance indicates that the device is substantially equivalent to a legally marketed predicate device and meets the regulatory requirements for its intended use.

• Are there different sizes or models of the Hollister-Stier House Dust Allergen Disc?

  The provided data does not specify multiple sizes or models for the Hollister-Stier House Dust Allergen Disc. It is identified as a singular diagnostic disc for house dust allergens under the product code DHB. For any variations or additional models, it is recommended to consult the manufacturer’s documentation or contact their support for detailed specifications.