# K042919: Fibrotek Fib

- Pathway: 510(k) (Traditional)
- Applicant: R2 Diagnostics, Inc.
- Decided: Nov 29, 2004 after 38 days
- Product code: GIS (Test, Fibrinogen)
- Device class: 2
- Regulation: 21 CFR 864.7340
- Recalls of this device: none
- 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. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K080826: Fibrinogen Assay Set. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The FibroTek FIB fibrinogen kit contains a lyophilized thrombin reagent, lyophilized calibrator plasma, and Imidazole Buffered Saline (IBS) for use in the quantitative determination of fibrinogen in citrated plasma. The fibrinogen test is a one-stage quantitative test performed on diluted plasma samples in the general patient population. The fibrinogen test is used to detect disorders of fibrinogen. The FibroTek FIB Fibrinogen Assay Kit should only be used in an appropriate clinical laboratory by qualified laboratory professionals.

Source page: https://510kreport.com/device/K042919
Methodology: https://510kreport.com/methodology