510(k) · Cleared

Cleared

Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105

K043007510(k) TraditionalCleared Nov 7, 2005371-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

Hyphen Biomed · JBQ Antithrombin Iii Quantitation

Cleared on Nov 7, 2005 as substantially equivalent to K915083 (Kabi Pharmacia, Inc., 1992) after a 371-day review. Its family tree reaches back 1 generation to 1992.

Decided: Nov 7, 2005
Review: 371 days
Class: Class II
Product code: JBQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K915083 (1992). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
This deviceK043007 Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin…Hyphen Biomed · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K915083	Coamate (R) Antithrombin Chromogenic Assay	Kabi Pharmacia, Inc.	1992	—
0 (this device)	K043007	Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5…	Hyphen Biomed	2005	—

FIG. 1 — Lineage of K043007, 1992–2005Source: 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
*	K915083	Coamate (R) Antithrombin Chromogenic Assay Summary page 1 …Classification Name: Antithrombin Ill Assay, Class II Regulation # 864.7060 Product Code: 81JBQ Identification of Predicate device: K915083 Coamatic ®Antithrombin ( Originaly named Coamatic Antithrombin) Description of the DevicelIntended use: Biophen Ant…	Kabi Pharmacia, Inc.	1992	—

Also cleared against K915083: 1 other device →

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?

Its one ancestor has no recall.
1 other device also cites its predicate K915083.

How does its category compare?

All JBQ devices

JBQ Antithrombin Iii Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

BIOPHEN Antithrombin 2.5 and 5 kit, is an in vitro diagnostic test for the quantitative determination of Antithrombin in human plasma, 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/K043007 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043007: Biophen Antithrombin 2.5, Reference # 221102; Biophen Antithrombin 5, Reference # 221105.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043007

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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