# K020798: Hemochron JR. Signature +

- Pathway: 510(k) (Special)
- Applicant: International Technidyne Corp.
- Decided: Mar 28, 2002 after 16 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: 2 generations back to K923761 (1993). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974799: Hemochron JR Generation II, Hemochron JR Signature, International Technidyne Corp. (1998) Summary page 1.

## Most influential descendants
- K050016: Hemochron Signature Elite (2005), 2 descendants of its own
- K193041: Hemochron Signature Elite (2019), 1 descendant of its own
- K202101: GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2 (2021), 0 descendants of its own

## Indications for use
The HEMOCHRON® Signature+ is a portable, battery-operated point of care microcoagulation instrument designed to perform whole blood coagulation tests using fresh or citrated whole blood. The system is intended for use in many clinical settings requiring point-of-care testing. Whole blood test results are displayed as clotting times (in seconds). The Signature+ also displays correlated celite equivalent ACT values, APTT and PT plasma equivalent values, and the PT INR value. For In Vitro Diagnostic Use Only

Source page: https://510kreport.com/device/K020798
Methodology: https://510kreport.com/methodology