# K941007: Catalog NO. J-Act+ & QC-Act+

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Jun 30, 1994 after 121 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K120977: Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette Directcheck Controls for Hemochron JR. Mic (2013), 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

Source page: https://510kreport.com/device/K941007
Methodology: https://510kreport.com/methodology