510(k) · Cleared
ClearedActichrome Heparin (Anti-Fxa), Model 832
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 Mar 8, 2002 as substantially equivalent to K923499 (Biopool AB, 1994) after a 154-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Mar 8, 2002
- Review
- 154 days
- Class
- Class II
- Product code
- KFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923499 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK923499 Spectrolyse Heparin KitBiopool AB · 1994
- This deviceK013318 Actichrome Heparin (Anti-Fxa), Model 832American Diagnostica, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923499 | Spectrolyse Heparin Kit | Biopool AB | 1994 | — |
| 0 (this device) | K013318 | Actichrome Heparin (Anti-Fxa), Model 832 | 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 |
|---|---|---|---|
| * | K923499 | Spectrolyse Heparin KitSummary page 1…Device: ACTICHROME?® Heparin (anti-fXa) Product No. 832 Classification: 864.7525 Heparin Assay, Class II Product Code KFF Predicate Device: Spectrolyse® Heparin (Xa) K923499 Intended Use: ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionat… | 1994 |
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-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight hcpanns in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. 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/K013318 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013318: Actichrome Heparin (Anti-Fxa), Model 832.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013318
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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