# K050817: T-TEK

- Pathway: 510(k) (Traditional)
- Applicant: R2 Diagnostics, Inc.
- Decided: Dec 12, 2005 after 256 days
- Product code: GJA (Test, Thrombin Time)
- Device class: 2
- Regulation: 21 CFR 864.7875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K884384 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K884384: Thrombin-Prest Reagent Kit, American Bioproducts Co. (1988) Summary page 1.

## Indications for use
The T-Tek Thrombin Time Reagent contains a lyophilized thrombin reagent, for use in the quantitative determination of thrombin time in citrated plasma. The thrombin time test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The thrombin time test is used to detect disorders of fibrinogen. The T-Tek, Thrombin Time Reagent should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

Source page: https://510kreport.com/device/K050817
Methodology: https://510kreport.com/methodology