Safe at Home TSH Blood Collection and Transport System
510(k) K011525
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011525 | Date16 Jul 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- Withdrawn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
- Full name
- Safe at Home Tsh (Thyroid Stimulating Hormone Blood Collection and Transport System)
- 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 Safe at Home TSH Blood Collection and Transport System is a radioimmunoassay device designed for the collection, storage, and transport of blood samples intended for thyroid-stimulating hormone (TSH) testing. It facilitates the accurate measurement of TSH levels in a clinical chemistry setting, supporting diagnostic evaluation of thyroid function disorders. The system ensures sample integrity from collection through laboratory analysis, reducing pre-analytical errors common in home or point-of-care testing environments.
This system is supplied as a single-use, non-sterile device for home or patient self-collection, followed by transport to a clinical laboratory. It is classified under FDA regulation 862.1690 as a Class II device and was granted FDA 510(k) clearance under the Traditional pathway in 2001. The device is intended for use in clinical chemistry laboratories and does not require MRI compatibility or special storage conditions beyond standard room temperature. Each unit is uniquely identified by the product code JLW and is intended for one-time use per collection kit.
Other devices from Biosafe Laboratories, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Safe at Home TSH Blood Collection and Transport System used for?
This system is designed for the collection, storage, and transport of blood samples specifically intended for thyroid-stimulating hormone (TSH) testing. It supports the diagnostic evaluation of thyroid function disorders by maintaining sample integrity from collection through laboratory analysis, which helps minimize errors that can occur in home or point-of-care settings.
How is the Safe at Home TSH system supplied and intended for use?
The system is supplied as a single-use, non-sterile device intended for home or patient self-collection. After collection, the sample is transported to a clinical laboratory for analysis. It is not meant for reuse or repeated use in the same collection kit.
Is sterility a requirement for the Safe at Home TSH system?
No, the Safe at Home TSH system is explicitly labeled as non-sterile. It is designed for one-time use in home or patient self-collection environments, where sterility is not required for the intended purpose of blood collection and transport.
What storage conditions are required for the Safe at Home TSH system?
The system does not require special storage conditions beyond standard room temperature. It is designed to be used immediately after collection and transported to a clinical laboratory without needing refrigeration or other controlled environmental conditions.
How do I identify the correct model or product code for the Safe at Home TSH system?
Each unit of the Safe at Home TSH system is uniquely identified by the product code JLW. This code helps distinguish it from other similar devices and ensures proper ordering and use in clinical settings.