# K960749: Hemochron JR. Microcoagulation Low Range Act

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Aug 12, 1996 after 171 days
- Product code: JBP (Activated Whole Blood Clotting Time)
- Device class: 2
- Regulation: 21 CFR 864.7140
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 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
- K992851: Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System (2000), 0 descendants of its own

## Recalls of this device
- Nov 5, 2025 · Class II · Z-0880-2026: Test cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of injury if not detected prior to handling.
- May 5, 2009 · Not classified · Z-1732-2009: One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
- Apr 27, 2005 · Not classified · Z-1381-05: Validation had been initiated for a molded component of the finished device but not completed. Also, the device did not meet mean clotting time using Normal Donor Blood as media.

Source page: https://510kreport.com/device/K960749
Methodology: https://510kreport.com/methodology