# K021023: Hemosil Normal Control (Assayed); Hemosil Normal Control 1 (Unassayed)

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 14, 2002 after 46 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 3 (0 Class I)
- 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.
3 later devices descend from it; 2 cite it directly.
0 of 5 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) Summary page 1.

## Most influential descendants
- K082859: Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed (2008), 1 descendant of its own
- K173202: CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, Coagpia Control Set (2018), 0 descendants of its own
- K110432: Visucon-F Frozen Coag Screen N, Visucon-F Frozen Coag Screen Abn (2011), 0 descendants of its own

## Recalls of this device
- Nov 15, 2013 · Class II · Z-0516-2014: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
- Nov 15, 2013 · Class II · Z-0515-2014: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
- Nov 15, 2013 · Class II · Z-0514-2014: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

## Indications for use
HemosIL Normal Control ASSAYED is intended for the quality control of coagulation assays in the normal range on IL Coagulation and ELECTRA™ Systems. The normal control is prepared using human citrated plasma from healthy donors. Values for all analytes are within the normal range.

Source page: https://510kreport.com/device/K021023
Methodology: https://510kreport.com/methodology