# K143470: Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

- Pathway: 510(k) (Traditional)
- Applicant: Diazyme Laboratories
- Decided: Jan 31, 2016 after 422 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
Longest line of descent: 1 generation back to K993482 (1999). 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)
- K993482: K-Assay Fibrinogen, Kamiya Biomedical Co. (1999) Summary page 5.

## Indications for use
The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only. The Diazyme Fibrinogen Calibrator Set is intended for use in the calibration of the Diazyme Fibrinogen Assay. For in vitro diagnostic use only. The Diazyme Fibrinogen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only. The performance of this device has not been established in neonate and pediatric patient populations.

Source page: https://510kreport.com/device/K143470
Methodology: https://510kreport.com/methodology