# K030964: Calibration Plasma LMW Heparin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jun 6, 2003 after 71 days
- Product code: JIS (Calibrator, Primary)
- Device class: 2
- Regulation: 21 CFR 862.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K002400 (2000). 1 ancestor in all.
7 later devices descend from it; 3 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)
- K002400: Modification of Acl Advance, Instrumentation Laboratory CO (2000)

## 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
- 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

## Indications for use
Calibration Plasma LMW Heparin is an in vitro diagnostic product intended as a tri-level calibrator to prepare calibration curves for use in chromogenic heparin assays.

Source page: https://510kreport.com/device/K030964
Methodology: https://510kreport.com/methodology