# K023582: I-Stat Kaolin Act Test

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corporation
- Decided: Sep 8, 2003 after 319 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Hemochron Activated Whole Blood Clotting Time (Hemochron KACT): named in the summary without a submission number

## Recalls of this device
- Oct 6, 2010 · Not classified · Z-0400-2011: Certain lots of i-STAT Celite ACT and Kaolin ACT cartridges may be difficult to fill or will not fill when attempting to transfer blood to the sample entry port of the cartridge.
- Aug 18, 2009 · Not classified · Z-0814-2010: Labeling discrepancy: The manual instruction state that the line should be flushed with 5 mL of saline and the first 5 mL of blood or six dead space volumes should be discarded. The Cartridge Test Inf

## Indications for use
The i-STAT Kaolin Activated Clotting Time (ACT) test is an in vitro diagnostic test used to monitor high-dose heparin anticoagulation frequently associated with cardiovascular surgery.

Source page: https://510kreport.com/device/K023582
Methodology: https://510kreport.com/methodology