# K974569: Coaguchek System, Coaguchek System for Prothrombin Time Self Testing

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 9, 1998 after 32 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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-0099-06: 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.
- Feb 20, 2003 · Not classified · Z-0720-03: Discrepancy between INR and the % Quick displayed on the meter.

## Indications for use
The CoaguChek System for professional use is intended for quantitative prothrombin time (PT) testing in fresh capillary or venous whole blood by professional health care providers. The CoaguChek System for Patient Self Testing is intended for the quantitative prothrombin time (PT) testing in fresh capillary blood by selected and suitably trained patients or their caregivers on the prescription of the treating physician.

Source page: https://510kreport.com/device/K974569
Methodology: https://510kreport.com/methodology