Additonal Allergens For Ige Fast (tm) Test
FDA 510(k)Class II (US FDA 510(k))
by 3m Company
Identifiers
- 510(k) Number
- K864104 FDA 510(k)
- FDA Product Code
- DHB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.5750 FDA 510(k)
- Regulation Number
- 866.5750 FDA 510(k)
- Advisory Committee
- Immunology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a System, Test, Radioallergosorbent (RAST) Immunological, designed for in vitro diagnostic testing of immunoglobulin E (IgE) antibodies to specific allergens. It is used to identify and quantify allergen-specific IgE in human serum or plasma, aiding in the diagnosis of allergic conditions such as asthma, hay fever, or food allergies.
The Additional Allergens for IGE FAST Test is supplied as a diagnostic reagent kit and is intended for single-use in clinical laboratory settings. It is classified as a Class II device under FDA regulations (21 CFR 866.5750) and has received FDA 510(k) clearance (K864104) under the Traditional 510(k) review pathway. The product includes multiple allergen-specific reagents, identified by unique registration numbers (e.g., 3000215273, 2517506), and is intended for use in immunology testing.
Frequently asked questions
What types of allergies can this test help diagnose, and how does it work?
This test is designed to identify and measure allergen-specific immunoglobulin E (IgE) antibodies in human serum or plasma, aiding in the diagnosis of allergic conditions such as asthma, hay fever, or food allergies. It works by detecting the presence and quantity of IgE antibodies that bind to specific allergens, helping clinicians confirm suspected allergies and tailor treatment plans accordingly.
Is this test kit meant for single-use only, and where would it be used?
Yes, the Additional Allergens for IGE FAST Test is intended for single-use in clinical laboratory settings. It is supplied as a diagnostic reagent kit and is not designed for repeated use or in-office point-of-care testing outside of a lab environment.
How many allergen-specific reagents does this kit include, and are they interchangeable?
The kit includes multiple allergen-specific reagents, each identified by unique registration numbers (e.g., 3000215273, 2517506). While the exact count varies by batch, these reagents are not interchangeable—they are tailored for specific allergen testing and must be used as directed in the accompanying instructions.
What regulatory pathway was followed for FDA clearance, and what does that mean for its use?
This device received FDA clearance under the Traditional 510(k) review pathway, classified as a Class II device (21 CFR 866.5750). The clearance means it has been determined to be substantially equivalent to a legally marketed predicate device, ensuring it meets established safety and performance standards for in vitro diagnostic use in immunology testing.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K864104 FDA 510(k) - ADDITONAL ALLERGENS FOR IGE FAST (TM) TEST, Additonal Allergens for Ige Fast (Tm) Test, Additonal Allergens for Ige Fast (Tm) Test, 3M MULTI-ALLERGEN IGE FASTSCREEN (TM) S8 - Innolitics, PDF 3M™/Neogen® Allergen Test - Nelson-Jameson
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K864104 | Class II | Active |
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Manufacturer
- Manufacturer
- 3m Company
Sources (1)
- FDA 510(k) K864104 24 fields · synced Sep 19, 2026