510(k) · Cleared
ClearedChromocheck Antithrombin 25; Chromocheck Antithrombin 50
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Precision Biologic · JBQ Antithrombin Iii Quantitation
Cleared on Apr 28, 2003 as substantially equivalent to K022195 (Instrumentation Laboratory CO, 2002) after a 146-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Apr 28, 2003
- Review
- 146 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K915083 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK915083 Coamate (R) Antithrombin Chromogenic AssayKabi Pharmacia, Inc. · 1992
- 2 generations backK980499 IL Test AntithrombinInstrumentation Laboratory CO · 1998
- 1 generation backK022195 Coamatic at-400Instrumentation Laboratory CO · 2002
- This deviceK023991 Chromocheck Antithrombin 25; Chromocheck Antithrombin 50Precision Biologic · 2003
- Descendant · cites it directly · 0 of its ownK050448 Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx · 2005
Most influential descendants
Showing 1 of 1 · See all- K050448Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K915083 | Coamate (R) Antithrombin Chromogenic Assay | Kabi Pharmacia, Inc. | 1992 | — |
| −2 | K980499 | IL Test Antithrombin | Instrumentation Laboratory CO | 1998 | — |
| −1 | K022195 | Coamatic at-400 | Instrumentation Laboratory CO | 2002 | — |
| 0 (this device) | K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 | Precision Biologic | 2003 | — |
| +1 | K050448 | Chromopep PC, Chromopep at, Models 2.5 and 5 | Horiba Abx | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 |
|---|---|---|---|
| * | K022195 | Coamatic at-400 | 2002 |
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 |
|---|---|---|---|
| K050448 | Chromopep PC, Chromopep at, Models 2.5 and 5 | 2005 | 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 11 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K050448 (Horiba Abx, 2005) 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?
ChromoCheckTMAntithrombin is intended for use as an in vitro chromogenic assay for the quantitative determination of antithrombin activity in citrated human plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023991 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023991: Chromocheck Antithrombin 25; Chromocheck Antithrombin 50.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023991
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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