# K970645: BC Thrombin Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: May 19, 1997 after 88 days
- Product code: GJA (Test, Thrombin Time)
- Device class: 2
- Regulation: 21 CFR 864.7875
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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) Behring Test Thrombin Reagent: named in the summary without a submission number

## Most influential descendants
- K060968: Stasis - I, II and Iii; Serathan - a, B; Intrin - EA, SI Calcium Chloride 0.02M; Fibrinogen Control-Normal, Low (2007), 0 descendants of its own

## Recalls of this device
- Oct 17, 2017 · Class II · Z-0827-2018: The BC Thrombin Reagent kit lot 46751 (contains Thrombin Reagent lot 517468) and kit lot 47184 (contains Thrombin Reagent lot 517469) produce unexpected prolonged Thrombin Time (TT) results for expect
- Jul 21, 2004 · Not classified · Z-0007-05: The product does not demonstrate the expected prolonged thrombin times for specimens obtained from patients recieving heparin

## Indications for use
The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in: - The monitoring of heparin therapy. - The monitoring of fibrinolysis therapy. The screening of disorders of fibrin formation. The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders. The BC Thrombin Reagent is used for the determination of the thrombin time in human plasma. The determination of thrombin time is important in: The monitoring of heparin therapy. The monitoring of fibrinolysis therapy. The screening of disorders of fibrin formation. The differentiating between a heparin-induced prolongation of the thrombin time and fibrin formation disorders.

Source page: https://510kreport.com/device/K970645
Methodology: https://510kreport.com/methodology