# K990449: Hemochron Electronic System Verification Tube

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Apr 13, 1999 after 60 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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 K940957 (1994). 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)
- K940957: Hemochron Verigy System/Factor VI Qualify System, International Technidyne Corp. (1994) Summary page 1.

## Indications for use
The HEMOCHRON® Electronic System Verification Tube is intended for in vitro diagnostic use in performing a quantitative electronic detection system verification of HEMOCHRON® Coagulation Instruments. The Electronic System Verification Tube electronically simulates test initiation and clot detection in the same manner as patient assay end points are recorded.

Source page: https://510kreport.com/device/K990449
Methodology: https://510kreport.com/methodology