# K992130: Pacific Hemostasis Thromboscreen 400C

- Pathway: 510(k) (Traditional)
- Applicant: Pacific Hemostasis
- Decided: Sep 3, 1999 after 72 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). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K894052: Electra 1000C Automatic Coagulation Timer, Medical Laboratory Automation Systems, Inc. (1989) Summary page 1.

## Indications for use
The Pacific Hemostasis ThromboScreen® 400C is a photo-optical instrument used for the performance of in-vitro diagnostic coagulation testing of citrated plasma samples in the clinical laboratory. The ThromboScreen® 400C has both clot and chromogenic testing capabilities. Assays performed on the instrument include routine clotting tests such as Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), Fibrinogen (Clauss and Derived methods), and PT and APTT-based factor assays. Chromogenic tests include assays such as Antithrombin III, Protein C and Heparin Xa.

Source page: https://510kreport.com/device/K992130
Methodology: https://510kreport.com/methodology