Autostat II Anti-PR 3 (C-ANCA) ELISA, Hy*Tec Anti-PR 3 (C-ANCA) ELISA
510(k) K990796
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK990796 | Date28 Apr 1999 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- MOB
- FDA applicant
- Cogent Diagnotics , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.5660
- Advisory Committee
- Immunology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
The Autostat II Anti-PR 3 (C-ANCA) ELISA and HyTec Anti-PR 3 (C-ANCA) ELISA are enzyme-linked immunosorbent assay methods for the semi-quantitative determination of specific IgG autoantibodies to PR 3 in human serum. These in vitro diagnostic assays are designed to detect IgG autoantibodies to PR 3, with the Autostat II being a manual or semi-automated kit and the HyTec version designed for use with the Hycor Hy-Tec Automated EIA instrument.
The device is manufactured by Cogent Diagnostics Ltd. and is supplied as a Class 2 immunology device with product code MOB. It received FDA 510(k) clearance with number K990796 on April 28, 1999, after a 49-day FDA review. The device is intended for in vitro diagnostic use and is not specified as single-use or reusable in the provided data.
Other devices from Cogent Diagnotics, Ltd.
Questions
AI-generated answers, 25 Sep 2026
What is the purpose of the Autostat II and Hy*Tec Anti-PR 3 (C-ANCA) ELISA?
These are enzyme-linked immunosorbent assay methods designed for the semi-quantitative determination of specific IgG autoantibodies to PR 3 in human serum, serving as in vitro diagnostic assays.
How are the Autostat II and Hy*Tec Anti-PR 3 (C-ANCA) ELISA supplied?
The Autostat II is supplied as a manual or semi-automated kit, while the Hy*Tec version is specifically designed for use with the Hycor Hy-Tec Automated EIA instrument.
What is the regulatory status of these diagnostic assays?
Both devices are Class 2 immunology devices with product code MOB, receiving FDA 510(k) clearance with number K990796 on April 28, 1999, after a 49-day FDA review.
Are these diagnostic assays single-use or reusable?
The provided data does not specify whether these diagnostic assays are single-use or reusable, only that they are intended for in vitro diagnostic use.