# K253985: INNOVANCE® D-Dimer 2.0 (SMN 10873803)

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostic Products GmbH
- Decided: Aug 11, 2026 after 242 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K862156 (1986). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093626: Innovance D-Dimer, Model OPBP09, Siemens Healthcare Diagnostics (2010) Summary page 5.

## Indications for use
INNOVANCE® D‑Dimer 2.0 is an in vitro diagnostic reagent for the quantitative, non-standardized determination of cross-linked fibrin degradation products (D-dimers). The INNOVANCE® D‑Dimer 2.0 reagent is intended for exclusion of deep vein thrombosis (DVT) and pulmonary embolism (PE) in conjunction with a clinical pretest probability (PTP) assessment model in outpatients suspected of DVT or PE in human sodium citrated plasma collected from venous blood samples in 3.2 % sodium citrate tubes. INNOVANCE® D‑Dimer 2.0 is for use on automated coagulation analyzers.

Source page: https://510kreport.com/device/K253985
Methodology: https://510kreport.com/methodology