Serodia ATG
by Fujirebio America, Inc. 510(k)
Active
510(k) K953066
Overview
Serodia ATG is an Antigen, Antiserum, Control for in vitro diagnostic use, designed for immunology applications. It is intended for the detection of antibodies in serological testing, specifically within the context of thyroid-related assays, such as thyroglobulin measurements.
This device is supplied as a single-use diagnostic reagent, intended for laboratory settings. It is classified under FDA regulation 866.5870 and holds a Traditional 510(k) clearance (K953066) with a Substantially Equivalent determination by the Immunology (IM) Advisory Committee. No third-party review is indicated, and sterility or MRI safety specifications are not referenced in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK953066 | Date14 Aug 1995 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DDC
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5870
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Fujirebio America, Inc.
Questions
What is the primary use of the Serodia ATG in laboratory testing?
The Serodia ATG is an antigen, antiserum, and control reagent designed specifically for in vitro diagnostic use in immunology applications. It is intended for detecting antibodies during serological testing, particularly in thyroid-related assays such as thyroglobulin measurements. This makes it useful for validating and calibrating tests that assess thyroid function or autoimmune thyroid conditions.
Is the Serodia ATG meant for single-use or repeated use in a laboratory setting?
The Serodia ATG is explicitly supplied as a single-use diagnostic reagent. This design ensures consistency and reliability in laboratory testing, as each vial is intended for one use only, reducing the risk of contamination or degradation over time.
What type of regulatory clearance does the Serodia ATG hold, and how was it determined?
The Serodia ATG holds a Traditional 510(k) clearance (K953066) from the FDA, determined to be substantially equivalent to a predicate device. This clearance was reviewed by the Immunology (IM) Advisory Committee, which evaluated its safety and performance for use in thyroid-related antibody detection assays.
Does the Serodia ATG require any special handling or storage conditions?
While the provided data does not specify exact storage conditions, the Serodia ATG is a single-use diagnostic reagent intended for laboratory use. Standard laboratory practices for storing diagnostic reagents—such as maintaining appropriate temperature ranges (typically 2–8°C) and protecting from light—are recommended to preserve its integrity until use.