# K093737: Hemosil F11 & FV Dna Control

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 4, 2010 after 151 days
- Product code: NZB (Quality Control Material, Genetics, Dna)
- Device class: 2
- Regulation: 21 CFR 866.5910
- 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 K083171 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083171: Introl CF Panel I Control, Model: G106, Maine Molecular Quality Controls, Inc. (2008) Summary page 1.

## Indications for use
HemosIL FII & FV DNA Control is intended for in vitro diagnostic use as a heterozygous quality control to monitor analytical performance of the extraction, amplification and detection steps of the Xpert HemosIL FII & FV genotyping assay on the GeneXpert® Dx System used in the detection of both the Factor II 20210G>A and Factor V 1691G>A (Leiden) mutations.

Source page: https://510kreport.com/device/K093737
Methodology: https://510kreport.com/methodology