510(k) · Cleared
ClearedHemosil Liquid Antithrombin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · JBQ Antithrombin Iii Quantitation
Cleared on Sep 1, 2006 as substantially equivalent to K033775 (Instrumentation Laboratory CO, 2004) after an 11-day review. Its family tree reaches back 4 generations to 1992. 1 later device descends from it.
- Decided
- Sep 1, 2006
- Review
- 11 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K915083 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
- 3 generations backK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
- 2 generations backK994238 IL Test Liquid AntithrombinInstrumentation Laboratory CO · 2000
- 1 generation backK033775 Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004
- This deviceK062431 Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006
- Descendant · cites it directly · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
Most influential descendants
Showing 1 of 1 · See all- K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd. · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K915083 | Coamate (R) Antithrombin Chromogenic Assay | Kabi Pharmacia, Inc. | 1992 | — |
| −3 | K980499 | IL Test Antithrombin | Instrumentation Laboratory CO | 1998 | — |
| −2 | K994238 | IL Test Liquid Antithrombin | Instrumentation Laboratory CO | 2000 | — |
| −1 | K033775 | Hemosil Liquid Antithrombin XL | Instrumentation Laboratory CO | 2004 | — |
| 0 (this device) | K062431 | Hemosil Liquid Antithrombin | Instrumentation Laboratory CO | 2006 | — |
| +1 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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 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
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 | Decided |
|---|---|---|---|
| * | K033775 | Hemosil Liquid Antithrombin XLSummary page 1…egulatory Information: 864.7060 Antithrombin III Assay Class II 81JBQ Antithrombin HII Quantitation Identification of Predicate Device(s): K033775 HemnosiL Liquid Antithrombin Device Description: HemroslL Liquid Antithrornbin is an automated chromogenic assay for the qua… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set | 2018 | 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?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 3.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K173202 (Sekisui Medical Co., Ltd., 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All JBQ devicesJBQ Antithrombin Iii Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JBQ
1in 2025
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
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 | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
HemoslL Liquid Antithrombin is an automated chromogenic assay for the quantitative determination of Antithrombin in human citrated plasma as an aid in the diagnosis of hereditary and acquired Antithrombin deficiency and to monitor Antithrombin substitution therapy.
This in vitro diagnostic test is based on a synthetic chromogenic substrate and on Factor Xa inactivation. As a consequence, it is specific and not influenced by Heparin Cofactor II.
Antithrombin levels in patient plasma are measured automatically on IL Coagulation Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062431 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062431: Hemosil Liquid Antithrombin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062431
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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