# K962571: Coaguchek PST System

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Apr 22, 1997 after 295 days
- Product code: GJS (Test, Time, Prothrombin)
- Device class: 2
- Regulation: 21 CFR 864.7750
- 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.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices 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) Boehringer Mannheim CoaguChek System: named in the summary without a submission number

## Most influential descendants
- K030845: Coaguchek PT.S Test for Prothrombin Time Self-Testing (2003), 3 descendants of its own
- K093243: Coagusense Self-Test Prothrombin Time/Inr Monitoring System (2010), 2 descendants of its own
- K183255: Coag-Sense Prothrombin Time (PT) / INR Monitoring Device (2019), 1 descendant of its own
- K212779: Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-Testing (2022), 0 descendants of its own

## Recalls of this device
- Feb 28, 2007 · Not classified · Z-0737-2007: The product was erroneously distributed to home users in contrast to its use for healthcare professionals only.
- Oct 18, 2006 · Not classified · Z-0227-2007: Erroneous Test Results: Monitor may display 'error' message or report falsely elevated patient results caused by insufficient amounts of active ingredient (thromboplastin) in the test strips.
- Mar 28, 2005 · Not classified · Z-0098-06: Breaking the glass ampoule without first taking precautions may result in cuts/user injury from the glass.
- Sep 12, 2003 · Not classified · Z-1293-03: Erroneous patient results: may be falsely elevated or lowered, due to a packaging defect that allows air and moisture to enter the sealed pouch.

## Indications for use
For quantitative prothrombin time (PT) testing in fresh capillary blood with the CoaguChek System by properly selected and suitably trained patients (or their care givers) on the prescription of the treating doctor.

Source page: https://510kreport.com/device/K962571
Methodology: https://510kreport.com/methodology