# K970431: Behring Coagulation System

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: May 5, 1997 after 90 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K926551 (1995). 2 ancestors in all.
2 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)
- K955278: Behring Coagulation Timer, Behring Diagnostics, Inc. (1996) Summary page 1.
- K926551: Behring Fibrintimer a, Behring Diagnostics, Inc. (1995) Summary page 1.

## Most influential descendants
- K020979: Sysmex Automated Coagulation Analyzer, Model #CA-7000 (2002), 1 descendant of its own
- K031377: Sysmex Automated Coagulation Analyzer CA500 Series (CA-510, -520, -530, -540. -550, and -560 (2003), 0 descendants of its own

## Recalls of this device
- Mar 2, 2021 · Class II · Z-1435-2021: Siemens Healthcare Diagnostics Products GmbH has confirmed that the BCS XP System may be affected by a potential Emicizumab carryover on patient samples.
- Jan 14, 2016 · Class II · Z-0825-2016: False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, h

## Indications for use
The Behring Coagulation System is an instrument intended to perform quantitative assays of specific parameters in plasma.

Source page: https://510kreport.com/device/K970431
Methodology: https://510kreport.com/methodology