AIACT Kit
by Sienco, Inc.
510(k) K032952
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK032952 | Date12 Dec 2003 | StatusActive |
Official records
- FDA 510(k) database K032952
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JBP
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7140
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The AIACT Kit is an in vitro diagnostic test for use with Sonoclot® Analyzer Systems. It is a celite/clay blend activated test that provides quantitative ACT and Clot Rate results for high dose heparin management.
The kit is intended for use with native whole blood and citrated whole blood, and is not affected by aprotinin. It includes cuvettes, probes, instructions for use, and reference plasma quality control. The device is FDA 510(k) cleared with product code JBP.
Devices cleared under K032952
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Sonoclot® aiACT Kit 800-0442 | 800-0442 / 800-0442 | B55880004421 | — | On the market |
Similar devices
Other devices filed under FDA product code JBP (Activated Whole Blood Clotting Time).
- HEMOTEC ACT I SYSTEM by Hemotec, Inc.
- HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME by Medical Device Consultants, Inc.
- CLOTTRAC COAGULATION CONTROL by Medtronic Hemotec, Inc.
- MAX-ACT by Array Medical, Inc.
- (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT by Cardiovascular Diagnostics, Inc.
- HEMOCHRON(R) KACT by International Technidyne Corp.
- ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE by Array Medical, Inc.
- HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT by International Technidyne Corp.
- CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL by Hemotec, Inc.
- i-STAT 03P87-25 by Abbott Point of Care Inc.