# K242952: INNOVANCE Antithrombin

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostic Products GmbH
- Decided: Mar 28, 2025 after 184 days
- Product code: JBQ (Antithrombin Iii Quantitation)
- Device class: 2
- Regulation: 21 CFR 864.7060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K933125 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933125: Berichrom Antithrombin Iii (a), Behring Diagnostics, Inc. (1994) Summary page 5.

## Indications for use
INNOVANCE 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. INNOVANCE Antithrombin is indicated as an aid in monitoring antithrombin activity to support QFITLIA (fitusiran) dosing in adult and pediatric patients aged 12 years and older with hemophilia A or B with or without factor VIII or IX inhibitors.

Source page: https://510kreport.com/device/K242952
Methodology: https://510kreport.com/methodology