# DEN200067: INNOVANCE VWF Ac

- Pathway: De Novo (Direct)
- Applicant: Siemens Healthcare Diagnostics Products GmbH
- Decided: Sep 29, 2022 after 701 days
- Product code: QTY (Von Willebrand Factor Assay)
- Device class: 2
- Regulation: 21 CFR 864.7293
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
In-vitro diagnostic automated assay for the quantitative determination of the von Willebrand factor-GPIb-binding activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS XP System. As an aid used in the evaluation of patients with suspected or confirmed von Willebrand factor disorders. Results of this test should always be interpreted in conjunction with the patient's medical history, clinical presentation and other laboratory findings.

Source page: https://510kreport.com/device/DEN200067
Methodology: https://510kreport.com/methodology