# K021024: Hemosil High Abnormal Control Assayed

- Pathway: 510(k) (Traditional)
- Applicant: Instrumentation Laboratory CO
- Decided: May 16, 2002 after 48 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 K864271 (1986). 4 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K931118: Assess (TM) High Abnormal Control, Instrumentation Laboratory CO (1994) Summary page 1.
- K864271: IL Test 84673-30 Chromogenics Control Plasma, Instrumentation Laboratory CO (1986) Summary page 1.
- K912711: IL Test Proclot Assay Stystem, Instrumentation Laboratory CO (1991) Summary page 1.
- K930327: IL Test (TM) Protein S, Instrumentation Laboratory CO (1993) 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 High Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the high abnormal range on IL Coagulation and ELECTRA™ Systems. The High Abnormal Control is prepared using human citrated plasma from healthy donors (not heparinized plasma or plasma samples under oral anticoagulant therapy) and modified to simulate an abnormal coagulation sample. Values for all analytes are in the high abnormal range.

Source page: https://510kreport.com/device/K021024
Methodology: https://510kreport.com/methodology