510(k) · Cleared
ClearedIL Test 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 Apr 2, 1998 as substantially equivalent to K915083 (Kabi Pharmacia, Inc., 1992) after a 52-day review. Its family tree reaches back 1 generation to 1992. 9 later devices descend from it.
- Decided
- Apr 2, 1998
- Review
- 52 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915083 (1992). 9 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
- This deviceK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
- Descendant · cites it directly · 4 of its ownK994238 IL Test Liquid AntithrombinInstrumentation Laboratory CO · 2000
- Descendant · cites it directly · 2 of its ownK033775 Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004
- Descendant · cites it directly · 2 of its ownK022195 Coamatic at-400Instrumentation Laboratory CO · 2002
- Descendant · 2 generations on · 1 of its ownK062431 Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006
- Descendant · 2 generations on · 1 of its ownK023991 Chromocheck Antithrombin 25; Chromocheck Antithrombin 50Precision Biologic · 2003
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K994238IL Test Liquid AntithrombinInstrumentation Laboratory CO · 2000 · cites it directly4descendants
- K033775Hemosil Liquid Antithrombin XLInstrumentation Laboratory CO · 2004 · cites it directly2descendants
- K022195Coamatic at-400Instrumentation Laboratory CO · 2002 · cites it directly2descendants
- K062431Hemosil Liquid AntithrombinInstrumentation Laboratory CO · 2006 · 2 generations on1descendant
- K023991Chromocheck Antithrombin 25; Chromocheck Antithrombin 50Precision Biologic · 2003 · 2 generations on1descendant
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) | K980499 | IL Test Antithrombin | Instrumentation Laboratory CO | 1998 | — |
| +1 | K994238 | IL Test Liquid Antithrombin | Instrumentation Laboratory CO | 2000 | — |
| +1 | K033775 | Hemosil Liquid Antithrombin XL | Instrumentation Laboratory CO | 2004 | — |
| +1 | K022195 | Coamatic at-400 | Instrumentation Laboratory CO | 2002 | — |
| +2 | K062431 | Hemosil Liquid Antithrombin | Instrumentation Laboratory CO | 2006 | — |
| +2 | K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 | Precision Biologic | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 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 |
|---|---|---|---|
| * | K915083 | Coamate (R) Antithrombin Chromogenic AssaySummary page 1…ice: IL Test™ Antithrombin Classification name(s): 864.7060 Antithrombin 1II Assay Class I1 81JBQ Antithrombin III Quantitation Identification of predicate device(s): K915083 Coamatic® Antithrombin (originally named Coamate Antithrombin) Description of the device/intended use(s): IL Test™ Antithrombi… | 1992 |
What descends from it? (9)
4 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?
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™ 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K980499 · printed Nov 6, 2026
Cite this page
510(k) Report. “K980499: IL Test Antithrombin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980499
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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