# 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

- Pathway: 510(k) (Traditional)
- Applicant: Accriva Diagnostics, Inc.
- Decided: Dec 29, 2021 after 518 days
- Product code: JPA (System, Multipurpose For In Vitro Coagulation Studies)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K923761 (1993). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193041: Hemochron Signature Elite, Accriva Diagnostics, Inc. (2019) Summary page 6.
- K941007: Catalog NO. J-Act+ & QC-Act+, International Technidyne Corp. (1994) Summary page 6.
- K960749: Hemochron JR. Microcoagulation Low Range Act, International Technidyne Corp. (1996) Summary page 6.
- K120977: Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette Directcheck Controls for Hemochron JR. Mic, International Technidyne Corp. (2013) Summary page 6.

## Recalls of this device
- Apr 30, 2026 · Class II · Z-2460-2026: Assayed Whole blood control contains labeling with incorrect performance range.

## Indications for use
GEM Hemochron 100 System: The GEMB HemochronTM 100 System is a battery-operated portable instrument that performs individual in vitro quantitative coagulation tests on fresh whole blood. The system is intended to be used with test cartridges available from the manufacturer and include tests for Activated Clotting Time (ACT+) and Low Range Activated Clotting Time (ACT LR).The system is intended for use only in point-of-care settings for patients aged 18 years and above The GEM HemochronTM 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® HemochronTM 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL The GEM® HemochronTM 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures. The GEM® HemochronTM 100 ACT-LR test demonstrates linear correlation to the anticoagulation effects of UFH concentrations up to 2.5 units/mL For in vitro diagnostic use. For Professional Use, Rx Only. GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+);: The GEM® HemochronTM 100 ACT+ (Activated Clotting Time Plus) test is a quantitative assay for monitoring anticoagulation with moderate to high unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during cardiovascular surgery and cardiac ablation procedures. The GEM® HemochronTM 100 ACT+ demonstrates linear correlation to the anticoagulation effects of UFH concentrations of 1.0 to 6.0 units/mL The GEMB HemochronTM 100 ACT+ test can be performed on the GEM® HemochronTM 100 System and any model of HemochronTM Signature Series device. Each instrument is portable, which allows testing at the pont-of-care. For in vitro diagnostic use. For Professional Use, Rx Only GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR): The GEM® HemochronTM 100 ACT-LR (Low Range Activated Clotting Time) test is a quantitative assay for monitoring anticoagulation with low to moderate unfractionated heparin (UFH) doses in fresh whole blood samples. This test is intended for monitoring UFH administered during extracorporeal life support and cardiology procedures The GEM® HemochronTM 100 ACT-LR test demonstrates linear correlation to the anticoagulation etfects of UFH concentrations up to 2.5 units/mL. The GEM Hemochron 100 ACT-LR test can be performed on the GEM® HemochronTM 100 system and any model of HemochronTM Signature Series device. Instruments are portable, which allows testing at the point-of-care. For in vitro diagnostic use For Professional Use, Rx Only directCHECK Whole Blood Controls: The directCHECKTM Whole Blood Quality Controls are dried whole blood preparations which have been assayed and are intended to be used to perfom quality control assays using the Hemochron'M test cartridges For in vitro Diagnostic Use. For Professional Use, Rx Only

Source page: https://510kreport.com/device/K202101
Methodology: https://510kreport.com/methodology