# K021976: Fibron-1, Fibron-4, Quikcoag, Fibron

- Pathway: 510(k) (Traditional)
- Applicant: Vital Scientific N.V.
- Decided: Oct 25, 2002 after 130 days
- Product code: KQG (Instrument, Coagulation)
- Device class: 2
- Regulation: 21 CFR 864.5400
- 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 K884863 (1989). 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)
- K884863: Electra 900C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1989) Summary page 2.

## Cited in the summary but kept off the family tree
- K883367: Calf Serum, Catalog NO. 110-1125, J R Scientific (1988). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Fibron-1 is a photo-optical instrument used for the performance of in-vitro diagnostic clotting testing of citrated plasma samples in the clinical laboratory. The Fibrin-1, which uses clot formation as an endpoint, may be used for the performance of the Prothrombin Time Test (PT) and the Activated Partial Thromboplastin Test (APTT).

Source page: https://510kreport.com/device/K021976
Methodology: https://510kreport.com/methodology