# AIACT Kit

> Active: United States. Medical device record on deviCERTS, compiled from public registries.

- Canonical page: <https://devicerts.com/devices/aiact-kit-jbp>
- Manufacturer: [Sienco, Inc.](https://devicerts.com/manufacturers/sienco-inc) (United States, FDA 510(k) applicant)
- Name in the registry: AIACT KIT
- Device class: Class II (US FDA)
- FDA product code: JBP

## Overview

*AI-generated summary, 2026-09-19. Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data is the record.*

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.

## Registrations and authorizations

- **510(k)** · FDA 510(k) · United States · K032952 · decision 2003-12-12 · decision SESE · status: Active

## Recalls

No recall on record.

## Identifiers

- 510(k) Number: K032952 [FDA 510(k)]
- FDA product code: JBP [FDA 510(k)]

## Classification

- Device class: Class II [FDA 510(k)]
- Regulation: 21 CFR Part 864.7140 [FDA 510(k)]
- Advisory committee: Hematology [FDA 510(k)]
- FDA decision: SESE [FDA 510(k)]

## Source and citation

- Cite as: AIACT Kit, Sienco, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/aiact-kit-jbp (data as of 2026-11-15).
- Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- Registry records last synced: 2026-10-06
- Statuses computed as of: 2026-11-15
- JSON: <https://devicerts.com/devices/aiact-kit-jbp.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/devices/aiact-kit-jbp
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.