510(k) · Cleared
ClearedINNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin UF and Heparin LMW Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics Prodcts GmbH · KFF Assay, Heparin
Cleared on Aug 22, 2017 as substantially equivalent to K983178 (Instrumentation Laboratory CO, 1998) after a 344-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- Aug 22, 2017
- Review
- 344 days
- Class
- Class II
- Product code
- KFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K935212 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK935212 IL Test Heparin (XA), PN 84699-15Instrumentation Laboratory CO · 1994
- 2 generations backK980242 IL Test HeparinInstrumentation Laboratory CO · 1998 · Recalled
- 1 generation backK983178 Coamatic HeparinInstrumentation Laboratory CO · 1998
- This deviceK162540 INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator…Siemens Healthcare Diagnostics Prodcts GmbH · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K935212 | IL Test Heparin (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994 | — |
| −2 | K980242 | IL Test Heparin | Instrumentation Laboratory CO | 1998 | 1 |
| −1 | K983178 | Coamatic Heparin | Instrumentation Laboratory CO | 1998 | — |
| 0 (this device) | K162540 | INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE… | Siemens Healthcare Diagnostics Prodcts GmbH | 2017 | — |
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? (1)
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 |
|---|---|---|---|
| * | K983178 | Coamatic HeparinSummary page 5…lass: Class II Product Code: GGN 510(k) Review Panel: Hematology 3 Predicate Device Coamatic Heparin Assay, K983178 (UFH and LMWH) A method comparison study for the above listed device was performed with the Coamatic Heparin assay on the Instru… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 2 companies; a new generation was cleared every 4.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All KFF devicesKFF Assay, Heparin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
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…
Read the full statement (142 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162540: INNOVANCE (r) Heparin Reagents, INNOVANCE (r) Heparin Calibrator, INNOVANCE (r) Heparin UF and Heparin LMW Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162540
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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