510(k) · Cleared
ClearedIL Test 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 Jun 23, 2000 as substantially equivalent to K980499 (Instrumentation Laboratory CO, 1998) after a 190-day review. Its family tree reaches back 2 generations to 1992. 4 later devices descend from it.
- Decided
- Jun 23, 2000
- Review
- 190 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915083 (1992). 4 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
- 1 generation backK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
- This deviceK994238 IL Test Liquid AntithrombinInstrumentation Laboratory CO · 2000
- Descendant · cites it directly · 2 of its ownK033775 Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004
- Descendant · 2 generations on · 1 of its ownK062431 Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006
- Descendant · 3 generations on · 0 of its ownK173202 CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator…Sekisui Medical Co., Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK022550 Coamatic LR Antithrombin, Note: LR=Liquid ReagentsInstrumentation Laboratory CO · 2002
Most influential descendants
Showing 4 of 4 · See all- K033775Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004 · cites it directly2descendants
- K062431Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006 · 2 generations on1descendant
- K173202CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control SetSekisui Medical Co., Ltd. · 2018 · 3 generations on0descendants
- K022550Coamatic LR Antithrombin, Note: LR=Liquid ReagentsInstrumentation Laboratory CO · 2002 · cites it directly0descendants
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) | K994238 | IL Test Liquid Antithrombin | Instrumentation Laboratory CO | 2000 | — |
| +1 | K033775 | Hemosil Liquid Antithrombin XL | Instrumentation Laboratory CO | 2004 | — |
| +2 | K062431 | Hemosil Liquid Antithrombin | Instrumentation Laboratory CO | 2006 | — |
| +3 | K173202 | CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia… | Sekisui Medical Co., Ltd. | 2018 | — |
| +1 | K022550 | Coamatic LR Antithrombin, Note: LR=Liquid Reagents | Instrumentation Laboratory CO | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K980499 | IL Test AntithrombinSummary page 1…L Test™ Liquid Antithrombin Classification Name(s): 864.7060 Antithrombin III Assay Class I1 81JBQ Antithrombin III Quantitation Identification of Predicate Device(s): K980499 IL Test™ Antithrombin Description of the Device/Intended use(s): IL Test™ Liquid Antithrombin is an automated chromogenic assay… | 1998 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 2 companies; a new generation was cleared every 6.2 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K033775 (Instrumentation Laboratory CO, 2004) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K980499.
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?
IL Test™ 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.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994238 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994238: IL Test 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/K994238
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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