# K102552: Hemosil LA Positive Control

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Apr 5, 2011 after 210 days
- Product code: GGC (Control, Plasma, Abnormal)
- 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 K935254 (1994). 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)
- K935254: Dvvtest and Dvvconfirm Lupus Anticoagulant Normal and Abnormal Control Plasma, American Diagnostica, Inc. (1994) Summary page 1.

## Indications for use
HemosiL LA Positive Control For use as an LA Positive Quality Control of Lupus Anticoagulant assays (HemoslL LAC Screen/LAC Confirm; HemoslL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)]. The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemoslL LA assays. HemoslL LA Negative Control For use as an LA Negative Quality Control of Lupus Anticoagulant assays (HemoslL LAC Screen/LAC Confirm; HemoslL Silica Clotting Time) on IL Coagulation systems [ACL TOP® Family; ACL ELITE®/ELITE PRO/8/9/10000; ACL Futura/ACL Advance; ACL Classic (100-7000)]. The control assesses the precision and accuracy of Lupus Anticoagulant (LA) tests performed on IL Coagulation Systems using HemosiL LA assays.

Source page: https://510kreport.com/device/K102552
Methodology: https://510kreport.com/methodology