510(k) · Cleared

Cleared

Hemosil Antithrombin

K070301510(k) SpecialCleared Feb 23, 200723-day reviewClass II21 CFR 864.7060

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

Instrumentation Laboratory CO · JBQ Antithrombin Iii Quantitation

Cleared on Feb 23, 2007 as substantially equivalent to K980499 (Instrumentation Laboratory CO, 1998) after a 23-day review. Its family tree reaches back 2 generations to 1992.

Decided: Feb 23, 2007
Review: 23 days
Class: Class II
Product code: JBQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K915083 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
1 generation backK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
This deviceK070301 Hemosil AntithrombinInstrumentation Laboratory CO · 2007

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K915083	Coamate (R) Antithrombin Chromogenic Assay	Kabi Pharmacia, Inc.	1992	—
−1	K980499	IL Test Antithrombin	Instrumentation Laboratory CO	1998	—
0 (this device)	K070301	Hemosil Antithrombin	Instrumentation Laboratory CO	2007	—

FIG. 1 — Lineage of K070301, 1992–2007Source: 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 JBQ? 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 JBQ device

#1 K242952 INNOVANCE Antithrombinscore 9.1 · 1 generation · no Class I recall

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What was it cleared against? (1)

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
*	K980499	IL Test Antithrombin Summary page 1 …Regulatory Information: 864.7060 Antithrombin 111 Assay Class II 81JBQ Antithrombin III Quantitation Identification of Predicate Device(s): K980499 HemoslL Antithrombin Device Description: HemoslL Antithrombin is an in vitro diagnostic test for the quantitative determina…	Instrumentation Laboratory CO	1998	—

Also cleared against K980499: 3 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 8.9 years on median.
None of the 2 ancestors has a recall.
3 other devices also cite its predicate K980499.

How does its category compare?

All JBQ devices

JBQ Antithrombin Iii Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · JBQ

1in 2025

2007high 1 (2007) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JBQ

Too few JBQ 510(k)s in any year since 2007 to give a median.

Recalls per year · JBQ

No recall names JBQ since 2007.

Adverse event reports per year · JBQ

1in 2023

2007high 1 (2013) · low 0 (2007)2025

MAUDE reports naming product code JBQ, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	1	—	0
2008	0	—	0
2009	1	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	1
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	1
2023	0	—	1
2024	0	—	0
2025	1	—	0
2026	0	—	—

What is it indicated for?

HemosLiL Antithrombin is an in vitro diagnostic test for the quantitative determination of Antihrombin in human plasma to monitor the administration of heparin in the treatment of thrombosis and as an aid in the diagnosis of thrombophilia (a congenital deficiency of Antithrombin).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K070301 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070301: Hemosil Antithrombin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070301

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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