510(k) · Cleared
ClearedEnoxaparin Test Card
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cardiovascular Diagnostics, Inc. · KFF Assay, Heparin
Cleared on Aug 23, 2002 as substantially equivalent to K925433 (American Bioproducts Co., 1995) after a 323-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Aug 23, 2002
- Review
- 323 days
- Class
- Class II
- Product code
- KFF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K925433 (1995). No later device cites it as a predicate yet.
- Root · 1 generation backK925433 The Stachrom Heparin Assay KitAmerican Bioproducts Co. · 1995
- This deviceK013305 Enoxaparin Test CardCardiovascular Diagnostics, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925433 | The Stachrom Heparin Assay Kit | American Bioproducts Co. | 1995 | — |
| 0 (this device) | K013305 | Enoxaparin Test Card | Cardiovascular Diagnostics, 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 |
|---|---|---|---|
| * | K925433 | The Stachrom Heparin Assay KitSummary page 2…S) or RapidpointTMCoag Enoxaparin (ENOX) Test Card Common Name: ENOX Test Card Classification Name: CFR Section 21 CFR 864.7525 Class II Predicate Device: K925433 Stachrom@HEPARIN ASSAY KIT Description of the Device: The Rapidpoint Enoxaparin (ENOX) test is a one-step dry coagulation metho… | 1995 |
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.
- 1 other device also cites its predicate K925433.
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?
The RapidpointTMCoagEnoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, 2 1.O IU/ml, of the low molecular weight heparin (LMWH), LovenoxWClexaneB (enoxaparin sodium)’, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX…
Read the full statement (135 words)
The RapidpointTMCoagEnoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, 2 1.O IU/ml, of the low molecular weight heparin (LMWH), LovenoxWClexaneB (enoxaparin sodium)’, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use at either the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.O IU/ml and the absence of drug.
The test provides information on the patient’s citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013305: Enoxaparin Test Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013305
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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