# K030965: Control Plasma LMW Heparin

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jun 6, 2003 after 71 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- 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
Control Plasma LMW Heparin is an in vitro diagnostic quality control material intended for use with chromogenic heparin assays to assess precision and accuracy at heparin low and high levels.

Source page: https://510kreport.com/device/K030965
Methodology: https://510kreport.com/methodology