# K980242: IL Test Heparin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Mar 19, 1998 after 55 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K935212 (1994). 1 ancestor in all.
7 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935212: IL Test Heparin (XA), PN 84699-15, Instrumentation Laboratory CO (1994) Summary page 1.

## Most influential descendants
- K090209: Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls (2009), 4 descendants of its own
- K213464: HemosIL Liquid Anti-Xa (2022), 2 descendants of its own
- K223187: HemosIL Liquid Anti-Xa (2023), 1 descendant of its own
- K983178: Coamatic Heparin (1998), 1 descendant of its own
- K240315: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (2024), 0 descendants of its own

## Recalls of this device
- Feb 3, 2025 · Class II · Z-2323-2025: 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

## Indications for use
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.

Source page: https://510kreport.com/device/K980242
Methodology: https://510kreport.com/methodology