# K992571: I-Stat System

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corp.
- Decided: Feb 10, 2000 after 192 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: 4 (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® Systems Activated Clotting Time: named in the summary without a submission number

## Recalls of this device
- Dec 3, 2010 · Not classified · Z-1341-2011: Celite ACT cartridges have increased numbers of values outside the accepted allowable error.
- Oct 6, 2010 · Not classified · Z-0399-2011: 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-0813-2010: 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
- Mar 16, 2005 · Not classified · Z-0912-05: Misidentification of Celite ACT cartridge as kaolin ACT Cartridge in the analyzer.

## Indications for use
The i-STAT Celite ACT test is useful for monitoring patients receiving heparin for treatment of pulmonary embolism or venous thrombosis, and for monitoring anticoagulation therapy in patients undergoing medical procedures such as catheterization, cardiac surgery, surgery, organ transplant and dialysis.

Source page: https://510kreport.com/device/K992571
Methodology: https://510kreport.com/methodology