Ames T-3 Uptake Strip Test
by Miles Laboratories, Inc. 510(k)
Active
510(k) K772088
Overview
The Ames T-3 Uptake Strip Test is a radioassay device for measuring triiodothyronine uptake, a diagnostic test used in clinical chemistry to evaluate thyroid function. It quantifies the binding affinity of thyroid hormones to serum proteins, aiding in the assessment of thyroid status by reflecting the metabolic activity of triiodothyronine (T3).
This device is a single-use, non-sterile in vitro diagnostic test supplied as a kit for laboratory use. It is classified under FDA regulation 862.1715 and was granted 510(k) clearance (K772088) in 1977, with a Substantially Equivalent (SESE) determination. Storage and handling follow standard laboratory protocols for radioactive materials, as it incorporates radiolabeled components.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772088 | Date6 Dec 1977 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- KHQ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1715
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Miles Laboratories, Inc.
Questions
What is the primary clinical use of the Ames T-3 Uptake Strip Test in a laboratory setting?
The Ames T-3 Uptake Strip Test is used as a radioassay device to measure triiodothyronine (T3) uptake, which helps evaluate thyroid function by assessing the binding affinity of thyroid hormones to serum proteins. This aids clinicians in determining thyroid metabolic activity and overall thyroid status.
Is the Ames T-3 Uptake Strip Test intended for single-use or repeated use, and what are the handling considerations?
The device is explicitly designed for single-use only. Since it contains radiolabeled components, it must be handled following standard laboratory protocols for radioactive materials to ensure safety and compliance.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its clinical chemistry classification?
The Ames T-3 Uptake Strip Test received FDA clearance through a 510(k) submission (K772088) in 1977, with a Substantially Equivalent (SESE) determination. It falls under the Clinical Chemistry advisory committee (CH) and is classified under FDA regulation 862.1715, confirming its role as an in vitro diagnostic device for thyroid function assessment.
Does the kit require sterilization before use, and what storage conditions should be followed?
The device is non-sterile and supplied as a single-use kit for laboratory testing. Storage should adhere to standard laboratory protocols for radioactive materials, as it includes radiolabeled components, but no additional sterilization is required before use.
Is this device still actively used today, or is it considered obsolete?
While the device received FDA clearance in 1977, its continued availability depends on manufacturer decisions and regulatory compliance. The Substantially Equivalent (SESE) classification suggests it remains within FDA’s regulatory framework, but clinicians should verify current availability with the manufacturer or distributor, as older diagnostic tests may be phased out in favor of newer technologies.