Praxsys Relia TSH Test
510(k) K011527
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011527 | Date7 Aug 2001 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JLW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1690
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Praxsys Relia TSH Test is a radioimmunoassay device designed for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma. It employs immunometric principles to detect TSH levels, aiding in the diagnosis and monitoring of thyroid disorders such as hypothyroidism, hyperthyroidism, and pituitary dysfunction. The test is categorized under clinical chemistry assays and is intended for in vitro diagnostic use in laboratory settings.
This device is supplied as a single-use reagent kit and requires no special environmental conditions beyond standard laboratory storage (2–8°C). It is not intended for MRI environments and must be handled according to manufacturer instructions for in vitro diagnostic use. The test is authorized under FDA 510(k) clearance (K011527) and classified as a Class II medical device (regulation number 862.1690). No third-party reprocessing is permitted, and sterility is maintained through sealed packaging until first use.
Questions
AI-generated answers, 1 Oct 2026
What is the Praxsys Relia TSH Test used for?
The Praxsys Relia TSH Test is designed for the quantitative measurement of thyroid-stimulating hormone (TSH) in serum or plasma samples. It employs immunometric principles to detect TSH levels, which aids clinicians in diagnosing and monitoring thyroid disorders such as hypothyroidism, hyperthyroidism, and pituitary dysfunction. This test is intended exclusively for in vitro diagnostic use in laboratory settings.
How is the Praxsys Relia TSH Test supplied and stored?
The test is supplied as a single-use reagent kit, meaning each kit is intended for one use only. It does not require special environmental conditions beyond standard laboratory storage temperatures of 2–8°C. The sealed packaging ensures sterility until first use, so it should be stored according to manufacturer instructions to maintain integrity.
Is the Praxsys Relia TSH Test reusable or reprocessable?
No, the Praxsys Relia TSH Test is strictly a single-use device. The manufacturer explicitly prohibits third-party reprocessing, and the kit is designed for one-time use only. This ensures accuracy and reliability of results, as reuse could compromise sterility and performance.
What regulatory clearance does the Praxsys Relia TSH Test hold?
The Praxsys Relia TSH Test holds FDA 510(k) clearance under the reference number K011527. It is classified as a Class II medical device under regulation number 862.1690, indicating it has been determined to be substantially equivalent to a legally marketed predicate device. This clearance confirms its compliance with U.S. regulatory standards for in vitro diagnostic use.
Can the Praxsys Relia TSH Test be used in MRI environments?
No, the Praxsys Relia TSH Test is not intended for use in MRI environments. The manufacturer’s instructions specify that it must be handled according to standard laboratory protocols, and there are no indications or assurances provided for compatibility with MRI settings. Always follow the manufacturer’s guidelines for safe and accurate use.