Insure Pro Test
510(k) K992695
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK992695 | Date18 Oct 1999 | 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- Withdrawn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
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Insure Pro Test is a Visual, Pregnancy Hcg device intended for prescription use. It is classified as a Class 2 medical device under the Clinical Chemistry specialty.
The device received FDA 510(k) clearance (K992695) through the Traditional pathway on October 18, 1999, following a determination of substantial equivalence. It is manufactured by Inbios Intl., Inc. and assigned product code JHI under regulation number 862.1155.
Other devices from Inbios Intl., Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Insure Pro Test used for?
The Insure Pro Test is a visual pregnancy HCG device intended for prescription use to detect human chorionic gonadotropin in urine or serum, aiding in the diagnosis of pregnancy.
How is the Insure Pro Test supplied and is it sterile or reusable?
The device is supplied as a visual test format for prescription use; however, the provided data does not specify sterility or single-use/reuse status, so no assumption can be made about these attributes.
What regulatory pathway and clearance number apply to the Insure Pro Test?
The Insure Pro Test received FDA 510(k) clearance through the Traditional pathway under K992695, determined to be substantially equivalent to a predicate device on October 18, 1999.