# K974799: Hemochron JR Generation II, Hemochron JR Signature

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Jul 7, 1998 after 197 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923761 (1993). 2 ancestors in all.
4 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)
- K923761: Itc Microsample Coagulation Analyzer System, International Technidyne Corp. (1993) Summary page 1.
- K940401: JR. Microcoagulation System, International Technidyne Corp. (1994) Summary page 1.

## Most influential descendants
- K020798: Hemochron JR. Signature + (2002), 3 descendants of its own
- 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

## Recalls of this device
- May 10, 2011 · Not classified · Z-2954-2011: Certain lots of Hemochron Jr. PT Cuvettes (J201) and GEM Test PT cartridges demonstrate a higher bias than historically observed when compared to laboratory reference. instruments.
- May 10, 2011 · Not classified · Z-2953-2011: Certain lots of Hemochron Jr. PT Cuvettes (J201) demonstrate a higher bias than historically observed when compared to laboratory reference instruments.

## Indications for use
The portable, battery operated HEMOCHRON® JR. SIGNATURE is a microcoagulation instrument designed to perform whole blood coagulation tests using fresh whole blood at the patient bedeside. The sgystem is intended to be used in many clinical gettings requiring point-of-care testing. Whole blood test reaults are displayed as clotting times, in sgeconds. The instrument also displays correlated celite equivalent values. The correlated values are based on regression analyses of comparative whole blood/plasma studies.

Source page: https://510kreport.com/device/K974799
Methodology: https://510kreport.com/methodology