510(k) · Cleared
Recalled · Class II · 2025IL Test Heparin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instrumentation Laboratory CO · KFF Assay, Heparin
Cleared on Mar 19, 1998 as substantially equivalent to K935212 (Instrumentation Laboratory CO, 1994) after a 55-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it. It has been recalled once.
- Decided
- Mar 19, 1998
- Review
- 55 days
- Class
- Class II
- Product code
- KFF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K935212 (1994). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK935212 IL Test Heparin (XA), PN 84699-15Instrumentation Laboratory CO · 1994
- This deviceK980242 IL Test HeparinInstrumentation Laboratory CO · 1998
- Descendant · cites it directly · 4 of its ownK090209 Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin…Instrumentation Laboratory CO · 2009 · Recalled
- Descendant · 2 generations on · 2 of its ownK213464 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · Recalled
- Descendant · 3 generations on · 1 of its ownK223187 HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023
- Descendant · cites it directly · 1 of its ownK983178 Coamatic HeparinInstrumentation Laboratory CO · 1998
- Descendant · 3 generations on · 0 of its ownK240315 INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05)…Siemens Healthcare Diagnostics Products GmbH · 2024
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K090209Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin ControlsInstrumentation Laboratory CO · 2009 · cites it directly4descendants
- K213464HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2022 · 2 generations on2descendants
- K223187HemosIL Liquid Anti-XaInstrumentation Laboratory CO · 2023 · 3 generations on1descendant
- K983178Coamatic HeparinInstrumentation Laboratory CO · 1998 · cites it directly1descendant
- K240315INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban…Siemens Healthcare Diagnostics Products GmbH · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K935212 | IL Test Heparin (XA), PN 84699-15 | Instrumentation Laboratory CO | 1994 | — |
| 0 (this device) | K980242 | IL Test Heparin | Instrumentation Laboratory CO | 1998 | — |
| +1 | K090209 | Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls | Instrumentation Laboratory CO | 2009 | 5 |
| +2 | K213464 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2022 | 2 |
| +3 | K223187 | HemosIL Liquid Anti-Xa | Instrumentation Laboratory CO | 2023 | — |
| +1 | K983178 | Coamatic Heparin | Instrumentation Laboratory CO | 1998 | — |
| +3 | K240315 | INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE… | Siemens Healthcare Diagnostics Products GmbH | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2009 | 1 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K935212 | IL Test Heparin (XA), PN 84699-15Summary page 1…ry 22, 1998 Name of the device: IL Test™ Heparin Classification name(s): 864.7525 Heparin Assay Class II 81KFF Assay, Heparin Identification of predicate device(s): K935212 IL Test™ Heparin Xa Description of the device/intended use(s): IL Test™ Heparin is an in vitro diagnostic test for the quantit… | 1994 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 3, 2025 | Class II | Z-2323-2025 | Process control | Multiple complaints indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range when testing is performed with HemosIL Liquid Anti-Xa and… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K090209 (Instrumentation Laboratory CO, 2009) has gone furthest, with 4 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.
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?
IL Test™ Heparin is an in vitro diagnostic test for the quantitative determination of
unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human
plasma. It is an automated heparin assay based on a synthetic chromogenic substrate and Factor
Xa inactivation.
Heparin is the most frequently used antithrombotic drug. The biological activity of this
sulphated glycosaminoglycan resides in its ability to accelerate (up to 2000-fold) the inhibitory
effect of antithrombin on coagulation proteases. In recent years, it has been shown that LMWH,
besides being as useful therapeutically as UFH, also has a longer half-life.
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/K980242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980242: IL Test Heparin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980242
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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