Identifiers
- 510(k) Number
- K032952 FDA 510(k)
- FDA Product Code
- JBP FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7140 FDA 510(k)
- Regulation Number
- 864.7140 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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.
Frequently asked questions
What is the AIACT Kit used for?
The AIACT Kit is an in vitro diagnostic test that provides quantitative ACT and Clot Rate results specifically for high dose heparin management when used with Sonoclot Analyzer Systems.
What types of blood samples can be used with the AIACT Kit?
The kit is designed for use with both native whole blood and citrated whole blood samples, and it is not affected by the presence of aprotinin.
What components are included in the AIACT Kit?
Each kit contains cuvettes, probes, instructions for use, and reference plasma quality control materials necessary for performing the activated clotting time test.
Is the AIACT Kit cleared by regulatory authorities?
Yes, the device is FDA 510(k) cleared with product code JBP, having been determined substantially equivalent to predicate devices for hematology applications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF over the probe mount hub. aiACT Kit - Sienco, SIENCO, INC. 800-0441 Sonoclot® aiACT Kit - RevMed, PDF Sienco, Inc. DEC 1 2 2003 - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K032952 | Class II | Active |
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Manufacturer
- Manufacturer
- Sienco, Inc.
Sources (1)
- FDA 510(k) K032952 24 fields · synced Sep 19, 2026