510(k) · Cleared
Recalled · Class II · 2026GEM 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accriva Diagnostics, Inc. · JPA System, Multipurpose For In Vitro Coagulation Studies
Cleared on Dec 29, 2021 as substantially equivalent to K193041 (Accriva Diagnostics, Inc., 2019) and 3 other predicates after a 518-day review. Its family tree reaches back 5 generations to 1993. It has been recalled once.
- Decided
- Dec 29, 2021
- Review
- 518 days
- Class
- Class II
- Product code
- JPA
- Recalls
- 1
- Predicates
- 4
Its longest line of descent runs back 5 generations to K923761 (1993). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK923761 Itc Microsample Coagulation Analyzer SystemInternational Technidyne Corp. · 1993
- 4 generations backK974799 Hemochron JR Generation II, Hemochron JR SignatureInternational Technidyne Corp. · 1998 · Recalled
- 3 generations backK020798 Hemochron JR. Signature +International Technidyne Corp. · 2002
- 2 generations backK050016 Hemochron Signature EliteInternational Technidyne Corp. · 2005
- 1 generation backK193041 Hemochron Signature EliteAccriva Diagnostics, Inc. · 2019
- This deviceK202101 GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time…Accriva Diagnostics, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K923761 | Itc Microsample Coagulation Analyzer System | International Technidyne Corp. | 1993 | — |
| −4 | K974799 | Hemochron JR Generation II, Hemochron JR Signature | International Technidyne Corp. | 1998 | 2 |
| −3 | K020798 | Hemochron JR. Signature + | International Technidyne Corp. | 2002 | — |
| −2 | K050016 | Hemochron Signature Elite | International Technidyne Corp. | 2005 | — |
| −1 | K193041 | Hemochron Signature Elite | Accriva Diagnostics, Inc. | 2019 | — |
| 0 (this device) | K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test… | Accriva Diagnostics, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 2 | 0 |
| 1996 | 1 | 0 |
| 2013 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JPA device
- #1 K243858 TEG 6s Hemostasis System Citrated: K, KH, RT…score 12.0 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K193041 | Hemochron Signature EliteSummary page 6…ame Predicate Device Predicate 510(k) Number Hemochron™ Signature Elite K193041 GEM® Hemochron™ 100 System Microcoagulation System… | 2019 |
| * | K941007 | Catalog NO. J-Act+ & QC-Act+Summary page 6…® Hemochron™ 100 System Microcoagulation System Hemochron™ Activated Clotting K941007 GEM® Hemochron™ 100 Time Plus (ACT+) Test Activated Clotting Time Plus Test… | 1994 |
| * | K960749 | Hemochron JR. Microcoagulation Low Range ActSummary page 6…Time Plus (ACT+) Test Activated Clotting Time Plus Test (ACT+) K960749 GEM® Hemochron™ 100 Low Hemochron™ Low Range Activated Range Activated Clotting Time Clotting Time… | 1996 |
| * | K120977 | Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette…Summary page 6…d Range Activated Clotting Time Clotting Time (ACT-LR) Test Test (ACT-LR) directCHECK™ Control for K120977 directCHECK™ ACT+ Whole Hemochron Jr. Microcoagulation Blood Controls, Level… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2026 | Class II | Z-2460-2026 | Process control | Assayed Whole blood control contains labeling with incorrect performance range. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 2 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 9 ancestors have a recall of any class.
How does its category compare?
All JPA devicesJPA System, Multipurpose For In Vitro Coagulation Studies: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · JPA
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JPA
30in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JPA
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JPA
11in 2025
MAUDE reports naming product code JPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 1 | 1,744 |
| 2008 | 2 | — | 0 | 918 |
| 2009 | 6 | 91 | 0 | 1,363 |
| 2010 | 1 | — | 6 | 727 |
| 2011 | 1 | — | 4 | 161 |
| 2012 | 0 | — | 1 | 52 |
| 2013 | 1 | — | 0 | 43 |
| 2014 | 0 | — | 0 | 48 |
| 2015 | 2 | — | 0 | 45 |
| 2016 | 6 | 114 | 3 | 6 |
| 2017 | 4 | 117 | 0 | 15 |
| 2018 | 1 | — | 0 | 39 |
| 2019 | 3 | 175 | 0 | 27 |
| 2020 | 0 | — | 1 | 18 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 1 | — | 0 | 9 |
| 2023 | 3 | 506 | 0 | 11 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 3 | 30 | 0 | 11 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
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…
Read the full statement (493 words)
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
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202101 · printed Nov 6, 2026
Cite this page
510(k) Report. “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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202101
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026