# K162540: INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin UF and Heparin LMW Controls

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Healthcare Diagnostics Prodcts GmbH
- Decided: Aug 22, 2017 after 344 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K935212 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K983178: Coamatic Heparin, Instrumentation Laboratory CO (1998) Summary page 5.

## Indications for use
INNOVANCE® Heparin Assay In vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS® XP System in the clinical laboratory. For use with plasma from patients undergoing heparin anticoagulant therapy with either UFH or LMWH. The performance of this device has not been established in neonate and pediatric patient populations. INNOVANCE® Heparin Calibrator For calibration of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma. INNOVANCE® Heparin UF and LMW Controls For quality control of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.

Source page: https://510kreport.com/device/K162540
Methodology: https://510kreport.com/methodology