510(k) · Cleared
ClearedCoamatic at-400
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 Aug 7, 2002 as substantially equivalent to K980499 (Instrumentation Laboratory CO, 1998) after a 33-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Aug 7, 2002
- Review
- 33 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K915083 (1992). 2 later devices descend from it, 1 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 deviceK022195 Coamatic at-400Instrumentation Laboratory CO · 2002
- Descendant · cites it directly · 1 of its ownK023991 Chromocheck Antithrombin 25; Chromocheck Antithrombin 50Precision Biologic · 2003
- Descendant · 2 generations on · 0 of its ownK050448 Chromopep PC, Chromopep at, Models 2.5 and 5Horiba Abx · 2005
Most influential descendants
Showing 2 of 2 · See allView 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) | K022195 | Coamatic at-400 | Instrumentation Laboratory CO | 2002 | — |
| +1 | K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 | Precision Biologic | 2003 | — |
| +2 | 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 |
|---|---|---|
| 2003 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K980499 | IL Test AntithrombinSummary page 1…cation Name(s): 864.7060 Antithrombin I11 Assay Class I1 8lJBQ Antithrombin I11 Quantitation Identification of Predicate Device(s): K980499 IL TestTMAntithrombin Description of the Devicedntended use(s): CoamaticB AT-400 is intended for the quantitative det… | 1998 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023991 | Chromocheck Antithrombin 25; Chromocheck Antithrombin 50 | 2003 | 1 |
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 10 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, K023991 (Precision Biologic, 2003) has gone furthest, with 1 descendant 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?
CoamaticB AT-400 is intended for the quantitative determination of the heparin cofactor activity of antithrombin (AT) in human citrated plasma.
Antithrombin is the most important natural inhibitor of the coagulation cascade. By inhibiting the coagulation proteases, especially thrombin, factor Xa and factor IXa, antithrombin prevents uncontrolled coagulation and thrombosis. Plasma is incubated with an excess of Factor Xa (FXa) in the presence of heparin. The residual activity of FXa is determined by the rate of hydrolysis of the chromogenic substrate S-2772. The pNA release measured at 405 nm is inversely proportional to the AT level in the range 10-125% of normal plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022195 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022195: Coamatic at-400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022195
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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