510(k) · Cleared
ClearedActichrome Heparin (Anti-Fiia)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Diagnostica, Inc. · KFF Assay, Heparin
Cleared on Apr 16, 2002 as substantially equivalent to K972209 (Medical Diagnostic Technologies, Inc., 1997) after a 162-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- Apr 16, 2002
- Review
- 162 days
- Class
- Class II
- Product code
- KFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972209 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972209 Spectrolyse Heparin (Anti-Iia)Medical Diagnostic Technologies, Inc. · 1997
- This deviceK013637 Actichrome Heparin (Anti-Fiia)American Diagnostica, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972209 | Spectrolyse Heparin (Anti-Iia) | Medical Diagnostic Technologies, Inc. | 1997 | — |
| 0 (this device) | K013637 | Actichrome Heparin (Anti-Fiia) | American Diagnostica, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K972209 | Spectrolyse Heparin (Anti-Iia)Summary page 1…ce: ACTICHROME® Heparin (anti-flla) Product No. 820 Classification: 864.7525 Heparin Assay, Class II Product Code KFF Predicate Device: Spectrolyse® Heparin (anti-Ila) K972209 Intended Use: ACTICHROME® Heparin (anti-fIla) is a chromogenic assay intended for the quantitative determination of therapeutic… | 1997 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KFF devicesKFF Assay, Heparin: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
ACTICHROME® Heparin (anti-flla) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor Ila (thrombin) inhibition. The Electra 900C® was used to determine performance data.
This kit is for in vitro diagnostic use.
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/K013637 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013637: Actichrome Heparin (Anti-Fiia).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013637
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026