# K082859: Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: Dec 19, 2008 after 81 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: 2 generations back to K002400 (2000). 10 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021023: Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed), Instrumentation Laboratory CO (2002) Summary page 1.
- K021022: Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (Unassayed), Instrumentation Laboratory CO (2002) Summary page 1.
- K021024: Hemosil High Abnormal Control Assayed, Instrumentation Laboratory CO (2002) Summary page 1.

## Most influential descendants
- K110432: Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn (2011), 0 descendants of its own

## Indications for use
HemosIL Routine Control Level 1 is for the quality control of coagulation assays in the normal range. The product is intended in the assessment of precision and accuracy for PT, APTT and Fibrinogen tests performed on coagulation systems. HemosIL Routine Control Level 2 is for the quality control of coagulation assays in the low abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems. HemosIL Routine Control Level 3 is for the quality control of coagulation assays in the high abnormal range. The product is intended in the assessment of precision and accuracy for PT and APTT tests performed on coagulation systems.

Source page: https://510kreport.com/device/K082859
Methodology: https://510kreport.com/methodology