# K090209: Hemosil Liquid Heparin, Heparin Calibrators and LMW and UF Heparin Controls

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jun 2, 2009 after 125 days
- Product code: KFF (Assay, Heparin)
- Device class: 2
- Regulation: 21 CFR 864.7525
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935212 (1994). 5 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980242: IL Test Heparin, Instrumentation Laboratory CO (1998) Summary page 1.
- K030964: Calibration Plasma LMW Heparin, Instrumentation Laboratory CO (2003) Summary page 1.
- K030965: Control Plasma LMW Heparin, Instrumentation Laboratory CO (2003) Summary page 1.

## Most influential descendants
- K213464: HemosIL Liquid Anti-Xa (2022), 2 descendants of its own
- K223187: HemosIL Liquid Anti-Xa (2023), 1 descendant of its own
- K240315: INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Apixaban Controls (OPPS05) (2024), 0 descendants of its own
- K163498: VALIDATE Heparin Calibration Verification/Linearity Test Kit (2017), 0 descendants of its own

## Recalls of this device
- Feb 3, 2023 · Class II · Z-1304-2023: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
- Feb 3, 2023 · Class II · Z-1306-2023: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
- Feb 3, 2023 · Class II · Z-1307-2023: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
- Feb 3, 2023 · Class II · Z-1305-2023: Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments
- Aug 25, 2021 · Class II · Z-0149-2022: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days

## Indications for use
HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems). HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems). HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems). HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).

Source page: https://510kreport.com/device/K090209
Methodology: https://510kreport.com/methodology