# K260214: STA® - Liquid Anti-Xa

- Pathway: 510(k) (Special)
- Applicant: Diagnostica Stago, Inc.
- Decided: Sep 24, 2026 after 244 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: 2 generations back to K854762 (1986). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111822: Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH, Diagnostica Stago, Inc. (2011) Summary page 6.

## Indications for use
STA® - Liquid Anti-Xa: The STA® Liquid Anti-Xa kits are intended for use with STA-R® family, STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate. STA® - Multi Hep Calibrator: The STA® -Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-xa activity. STA® - Quality HNF/UFH: The STA® -Quality HNF/UFH kit is set of two plasmas intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact® , and STA Satellite® analyzers. STA® - Quality HBPM/LMWH: STA® - Quality HBPM/LMWH kit is a set of two plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers.

Source page: https://510kreport.com/device/K260214
Methodology: https://510kreport.com/methodology