Preg-Stat RIA Kit
by Serono Laboratories, Inc. 510(k)
Active
510(k) K781733
Overview
The Preg-Stat RIA Kit is a radioimmunoassay (RIA) kit designed for the quantitative measurement of human chorionic gonadotropin (hCG) in serum or urine. It employs radioisotope-based technology to detect and quantify pregnancy-related hCG levels, aiding in the diagnosis of pregnancy status. This device falls under the category of visual pregnancy hCG tests and is intended for prescription use in clinical chemistry settings.
The kit is supplied as a single-use diagnostic reagent system and requires no special storage conditions beyond those specified in the accompanying instructions. It is classified as a Class II medical device under FDA regulations (862.1155) and was granted FDA 510(k) clearance in 1978. The device is intended for use in laboratory environments and is not MRI-compatible or reusable. No additional regulatory approvals beyond the 510(k) clearance are referenced in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781733 | Date20 Dec 1978 | 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- Withdrawn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
- Full name
- Ria Kit, Preg-Stat
- 510(k) Number
- FDA Product Code
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Serono Laboratories, Inc.
Questions
What is the Preg-Stat RIA Kit used for?
The Preg-Stat RIA Kit is designed for the quantitative measurement of human chorionic gonadotropin (hCG) in serum or urine samples. hCG is a hormone produced during pregnancy, and its levels are used to confirm or assess pregnancy status. This kit employs radioimmunoassay technology to provide precise detection and quantification, making it suitable for clinical chemistry laboratories.
How is the Preg-Stat RIA Kit supplied and stored?
The Preg-Stat RIA Kit is supplied as a single-use diagnostic reagent system. It does not require special storage conditions beyond those outlined in the accompanying instructions. Always follow the manufacturer’s guidelines to ensure proper handling and storage to maintain the kit’s integrity and accuracy.
Is the Preg-Stat RIA Kit reusable or single-use?
The Preg-Stat RIA Kit is intended for single-use only. This design ensures accuracy and reliability for each test, as reuse could compromise the integrity of the radioimmunoassay process and lead to inaccurate results.
What type of regulatory clearance does the Preg-Stat RIA Kit have?
The Preg-Stat RIA Kit holds FDA 510(k) clearance, which means it has been determined to be substantially equivalent to a legally marketed device. This clearance was granted in 1978 under the FDA’s regulatory pathway for Class II medical devices, specifically for visual pregnancy hCG tests intended for prescription use in clinical settings.
Can the Preg-Stat RIA Kit be used outside of a laboratory environment?
No, the Preg-Stat RIA Kit is explicitly intended for use in laboratory environments. The radioimmunoassay technology and precise measurement requirements make it unsuitable for point-of-care or home use. It is not designed for MRI compatibility or non-laboratory settings.