Architect Free T4
by Abbott Laboratories 510(k)
Active
510(k) K123379
Overview
The Abbott Architect Free T4 is a chemiluminescent microparticle immunoassay (CMIA) device designed for the quantitative measurement of free thyroxine (T4) in human serum or plasma. It falls under the category of radioimmunoassay systems and is intended for use in clinical chemistry laboratories to assess thyroid function by determining unbound thyroxine levels.
This device is supplied as a reagent kit (e.g., 7K65G) and is intended for in vitro diagnostic use on the Abbott Architect i System. It is classified as a Class II medical device under FDA regulations (862.1695) and has received FDA 510(k) clearance (K123379) as substantially equivalent to a predicate device. The assay requires laboratory personnel to operate and is not intended for single-use or reusable applications beyond its specified reagent shelf life.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK123379 | Date27 Nov 2012 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Abbott Architect Free T4
- 510(k) Number
- FDA Product Code
- CEC
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1695
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Abbott Architect Free T4 used for in a clinical setting?
The Abbott Architect Free T4 is a chemiluminescent microparticle immunoassay (CMIA) device designed specifically to measure unbound (free) thyroxine (T4) levels in human serum or plasma. It helps clinicians assess thyroid function by quantifying the active fraction of T4 that is not bound to proteins, providing critical insights for diagnosing or monitoring thyroid disorders like hyperthyroidism or hypothyroidism.
How is the Abbott Architect Free T4 supplied, and what system does it require?
The device is supplied as a reagent kit (e.g., catalog number 7K65G) and is intended for use exclusively on the Abbott Architect i System. It is not a standalone device but rather a consumable component that must be paired with the Architect i platform to perform the assay.
Is the Abbott Architect Free T4 intended for single-use or reusable applications?
The Abbott Architect Free T4 is not designed for single-use or reuse beyond its specified reagent shelf life. It is a multi-test reagent kit meant for laboratory use, where the reagents are consumed during testing and replaced as needed. The device itself is not reusable—only the system it runs on is intended for repeated use.
What type of regulatory clearance does the Abbott Architect Free T4 hold, and how was it classified?
The Abbott Architect Free T4 received FDA 510(k) clearance (K123379) under a Special 510(k) pathway, with a decision classification of Substantially Equivalent (SESE) to a predicate device. It is classified as a Class II medical device under FDA regulations (862.1695), indicating moderate risk and requiring premarket notification. The device falls under the Clinical Chemistry advisory committee category.