# K020355: I-Stat Prothrombin Time Test

- Pathway: 510(k) (Traditional)
- Applicant: I-Stat Corporation
- Decided: May 14, 2002 after 99 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- Recalls of this device: 5 (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) Coaguchek S System: named in the summary without a submission number

## Recalls of this device
- Jun 15, 2015 · Class II · Z-2361-2015: Certain lots of PT/INR cartridges may generate a higher than typical number of PT/INR star outs potentially delaying the generation of patient results for PT/INR.
- Oct 28, 2013 · Class II · Z-0451-2014: Abbott Point of Care Inc (APOC) has determined that i-Stat PT/INR cartridges have the potential to exhibit incorrectly elevated INR.
- Mar 1, 2012 · Class II · Z-2157-2012: The i-STAT PT/INR cartridges have the potential to exhibit incorrectly elevated results.
- May 5, 2010 · Not classified · Z-1996-2010: A high mean bias (12-16%) was documented in 8 lots of i-STAT PT/INR cartridges. This may lead a clinician to believe that a patient is adequately anticoagulated when they are not. Inadequate anticoagl
- Dec 12, 2006 · Not classified · Z-0364-2007: Patients treated with the antibiotic CUBICIN can cause a concentration dependent false prolongation of prothrombin time (PT) and elevation of INR (International Normalized Ratio) when using the i-STAT

## Indications for use
The i-STAT PT, a prothrombin time test, is useful for monitoring patients receiving oral anticoagulation therapy such as Coumadin or warfarin.

Source page: https://510kreport.com/device/K020355
Methodology: https://510kreport.com/methodology