# K111822: Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostica Stago, Inc.
- Decided: Oct 26, 2011 after 120 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K854762 (1986). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010455: Rotachrom Heparin and Sta -Rotachrom Heparin, Diagnostica-Stago (2001) Summary page 1.
- K010350: Sta -Calibrator HBPM/LMWH Kit, Diagnostica Stago, Inc. (2001) Summary page 1.
- K854762: Hepanorm Calibration Plasma Set, American Bioproducts Co. (1986) Summary page 1.
- K943520: Heparin Control Kit, American Bioproducts Co. (1995) Summary page 1.
- K010324: Sta-Quality HBPM/LMWH Kit, Diagnostica Stago, Inc. (2001) Summary page 1.

## Most influential descendants
- K260214: STA® - Liquid Anti-Xa (2026), 0 descendants of its own

## Recalls of this device
- Jul 21, 2025 · Class II · Z-2475-2025: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Jul 21, 2025 · Class II · Z-2474-2025: Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
- Jul 18, 2014 · Class III · Z-2650-2014: Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

## Indications for use
The STA® - Liquid Anti-Xa kits are intended for use with STA-R®, 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. 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. The STA® - Quality HNF/UFH kit is a 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. The 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/K111822
Methodology: https://510kreport.com/methodology