510(k) · Cleared
ClearedInnovance Antithrombin with Models OPFH03, OPFHO5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · JBQ Antithrombin Iii Quantitation
Cleared on May 28, 2009 as substantially equivalent to K933125 (Behring Diagnostics, Inc., 1994) after a 339-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- May 28, 2009
- Review
- 339 days
- Class
- Class II
- Product code
- JBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933125 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK933125 Berichrom Antithrombin Iii (a)Behring Diagnostics, Inc. · 1994
- This deviceK081769 Innovance Antithrombin with Models OPFH03, OPFHO5Siemens Healthcare Diagnostics · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933125 | Berichrom Antithrombin Iii (a) | Behring Diagnostics, Inc. | 1994 | — |
| 0 (this device) | K081769 | Innovance Antithrombin with Models OPFH03, OPFHO5 | Siemens Healthcare Diagnostics | 2009 | — |
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 |
|---|---|---|---|
| * | K933125 | Berichrom Antithrombin Iii (a)Summary page 1…JBQ Panel: Hematology 3. Identification of the Legally Marketed Device: Dade Behring Berichrom TM Antithrombin III (A)- K933125 4. Device Description: The INNOVANCETM Antithrombin assay utilizes a chromogenic measuring principle. An… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K933125.
How does its category compare?
All JBQ devicesJBQ Antithrombin Iii Quantitation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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?
INNOVANCETM Antithrombin is a chromogenic assay for the automated quantitation of functionally active antithrombin in human citrated plasma and can be used as an aid in the diagnosis of antithrombin deficiency.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081769 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081769: Innovance Antithrombin with Models OPFH03, OPFHO5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081769
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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