510(k) · Cleared

Cleared

Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette Directcheck Controls for Hemochron JR. Mic

K120977510(k) TraditionalCleared Jul 3, 2013457-day reviewClass II21 CFR 864.5425

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

International Technidyne Corp. · GGN Plasma, Coagulation Control

Cleared on Jul 3, 2013 as substantially equivalent to K960749 (International Technidyne Corp., 1996) and 1 other predicate after a 457-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.

Decided: Jul 3, 2013
Review: 457 days
Class: Class II
Product code: GGN
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K941007 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK941007 Catalog NO. J-Act+ & QC-Act+International Technidyne Corp. · 1994
This deviceK120977 Directcheck Control for Hemochron JR. Microcoagulation Systems…International Technidyne Corp. · 2013
Descendant · cites it directly · 0 of its ownK202101 GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time…Accriva Diagnostics, Inc. · 2021 · Recalled

Most influential descendants

Showing 1 of 1 · See all

K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…Accriva Diagnostics, Inc. · 2021 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K941007	Catalog NO. J-Act+ & QC-Act+	International Technidyne Corp.	1994	—
0 (this device)	K120977	Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette…	International Technidyne Corp.	2013	—
+1	K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test…	Accriva Diagnostics, Inc.	2021	1

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2021	1	0

FIG. 1 — Lineage of K120977, 1994–2021Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 GGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

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	Applicant	Decided	Recalls
*	K960749	Hemochron JR. Microcoagulation Low Range Act Summary page 1 …Trade name: HEMOCHRON® Jr. Microcoagulation Low Range ACT including whole blood controls Normal / Abnormal 5 10(k) number: K960749 Manufacturer: International Technidyne Corporation (ITC), Edison, NJ Trade name: HEMOCHRON® Jr. Mic…	International Technidyne Corp.	1996	3
*	K941007	Catalog NO. J-Act+ & QC-Act+ Summary page 1 …de name: HEMOCHRON® Jr. Microcoagulation ACT± test cuvette including whole blood controls Normal / Abnormal 5 10(k) number: K941007 Manufacturer: International Technidyne Corporation (ITC), Edison, NJ IDI 807.92 (a)(4): Device Description…	International Technidyne Corp.	1994	—

Also cleared against K960749: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…	Accriva Diagnostics, Inc.	2021	0

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

1 of the 2 ancestors has a recall of any class.
Of its descendants, K202101 (Accriva Diagnostics, Inc., 2021) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K960749.

How does its category compare?

All GGN devices

GGN Plasma, Coagulation Control: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · GGN

4in 2017

2007high 4 (2017) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GGN

96in 2017

2007high 441 (2013) · low 23 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GGN

1in 2019

2007high 4 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GGN

4in 2018

2007high 37 (2009) · low 0 (2007)2025

MAUDE reports naming product code GGN, 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	3	47	0	0
2008	1	—	0	0
2009	2	—	0	37
2010	3	23	4	17
2011	2	—	1	30
2012	1	—	0	10
2013	3	441	3	9
2014	2	—	0	5
2015	0	—	0	10
2016	2	—	0	9
2017	4	96	0	11
2018	0	—	0	4
2019	0	—	1	0
2020	0	—	0	0
2021	0	—	0	0
2022	0	—	0	0
2023	0	—	0	0
2024	0	—	0	0
2025	0	—	0	0
2026	0	—	2	—

What is it indicated for?

The directCHECK® Whole Blood ACT+ Level I (normal) and ACT+ Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT+ assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments.

The directCHECK® Whole Blood ACT-LR Level I (normal) and ACT-LR Level 2 (abnormal) Controls are assayed lyophilized whole blood preparations intended for the quality control of quantitative coagulation test: HEMOCHRON® ACT-LR assay on the HEMOCHRON® Jr. Signature+ and HEMOCHRON® Signature Elite instruments

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K120977 · printed Nov 4, 2026

Cite this page

510(k) Report. “K120977: Directcheck Control for Hemochron JR. Microcoagulation Systems Act-LR Cuvette Directcheck Controls for Hemochron JR. Mic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K120977

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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