510(k) · Cleared
Recalled · Class II · 2025Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostica Stago, Inc. · KFF Assay, Heparin
Cleared on Oct 26, 2011 as substantially equivalent to K010455 (Diagnostica-Stago, 2001) and 4 other predicates after a 120-day review. Its family tree reaches back 1 generation to 1986. 1 later device descends from it. It has been recalled 3 times.
- Decided
- Oct 26, 2011
- Review
- 120 days
- Class
- Class II
- Product code
- KFF
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 1 generation to K854762 (1986). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK854762 Hepanorm Calibration Plasma SetAmerican Bioproducts Co. · 1986
- This deviceK111822 Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh…Diagnostica Stago, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK260214 STA® - Liquid Anti-XaDiagnostica Stago, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K854762 | Hepanorm Calibration Plasma Set | American Bioproducts Co. | 1986 | — |
| 0 (this device) | K111822 | Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality… | Diagnostica Stago, Inc. | 2011 | — |
| +1 | K260214 | STA® - Liquid Anti-Xa | Diagnostica Stago, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in KFF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KFF device
- #1 K260214 STA® - Liquid Anti-Xascore 12.4 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (5)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K010455 | Rotachrom Heparin and Sta -Rotachrom HeparinSummary page 1…sma, coagulation control STA” - Quality HBPM/LMWH | Heparin Control 21 CFR 864 5425 GGN Predicate Devices Predicate Device name 510(k) number STA® - Rotachrom® Heparin K010455 STA® - Calibrator HBPM/LMWH "1K010350 STA®- HepanormrH {formerly cleared as Hepanorm® K854762 Calibration Plasma Set} STA® - H… | 2001 |
| * | K010350 | Sta -Calibrator HBPM/LMWH KitSummary page 1…HBPM/LMWH | Heparin Control 21 CFR 864 5425 GGN Predicate Devices Predicate Device name 510(k) number STA® - Rotachrom® Heparin K010455 STA® - Calibrator HBPM/LMWH "1K010350 STA®- HepanormrH {formerly cleared as Hepanorm® K854762 Calibration Plasma Set} STA® - Heparin Control K943520 STA® - Quality… | 2001 |
| * | K854762 | Hepanorm Calibration Plasma SetSummary page 1…te Devices Predicate Device name 510(k) number STA® - Rotachrom® Heparin K010455 STA® - Calibrator HBPM/LMWH "1K010350 STA®- HepanormrH {formerly cleared as Hepanorm® K854762 Calibration Plasma Set} STA® - Heparin Control K943520 STA® - Quality HBPM/LMWH K010324 Page 1 of 5… | 1986 |
| * | K943520 | Heparin Control KitSummary page 1…otachrom® Heparin K010455 STA® - Calibrator HBPM/LMWH "1K010350 STA®- HepanormrH {formerly cleared as Hepanorm® K854762 Calibration Plasma Set} STA® - Heparin Control K943520 STA® - Quality HBPM/LMWH K010324 Page 1 of 5 Stago Device Intended Us… | 1995 |
| * | K010324 | Sta-Quality HBPM/LMWH KitSummary page 1…Calibrator HBPM/LMWH "1K010350 STA®- HepanormrH {formerly cleared as Hepanorm® K854762 Calibration Plasma Set} STA® - Heparin Control K943520 STA® - Quality HBPM/LMWH K010324 Page 1 of 5 Stago Device Intended Use V STA® - Liquid Anti-Xa: The… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260214 | STA® - Liquid Anti-Xa | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 21, 2025 | Class II | Z-2475-2025 | Mixed-up of materials/components | 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 | Mixed-up of materials/components | 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 | Under Investigation by firm | Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 5 ancestors has a recall.
- Of its descendants, K260214 (Diagnostica Stago, Inc., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KFF devicesKFF Assay, Heparin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KFF
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · KFF
Too few KFF 510(k)s in any year since 2007 to give a median.
Recalls per year · KFF
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KFF
7in 2025
MAUDE reports naming product code KFF, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 1 | 4 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 1 | 0 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (165 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K111822 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111822: Sta (R) - Liquid Anti-XA, Multi Hep Calibrator, Quality HNF / Ufh, Quality HBPM / LMWH.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111822
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026