# K113211: Hemosil LA Positive Control & Hemosil LA Negative Control

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Jan 4, 2012 after 65 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: 3 generations back to K922156 (1993). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110031: Hemosil Drvvt Screen & Hemosil Drvvt Confirm, Instrumentation Laboratory CO (2011) Summary page 2.

## Indications for use
HemosiL LA Positive Control is intended for use as an LA Positive Quality Control of Lupus Anticoagulant assays (Hemo5IL dRWVT Screen/dRVVT Confirm, Hemosl LAC Screen/LAC Confirm and H-emosiL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOP* Family; ACL ELITE /ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)]. H-emosiL LA Negative Control is intended for use as an IA Negative Quality Control of Lupus Anticoagulant assays (HemoslL dRVVT Screen/dRVVT Confirm, HemoslL LAC Screen/LAC Confirm and HemoslL Silica Clotting Time Screen and Confirm) on IL Coagulation systems [ACL TOPO Family; ACI ELITE /ELITE PRO/8/9/10000; ACI Futura/ACL Advance; AdL Classic (100-7000)].

Source page: https://510kreport.com/device/K113211
Methodology: https://510kreport.com/methodology