# K021022: Hemosil Low Abnormal Controlled (Assayed); Hemosil Low Abnormal Control 2 (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 K864271 (1986). 5 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K931117: Assess (TM) Low 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.
- K000679: Thrombostrate Control Plasmas, Pacific Hemostasis (2000) Summary page 1.

## Most influential descendants
- K082859: Hemosil Routine Control Level 1, Level 2, Level 3 Unassayed (2008), 1 descendant 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 Low Abnormal Control ASSAYED is intended for the quality control of coagulation assays in the low abnormal range on IL Coagulation and ELECTRA™ Systems. The Low Abnormal Control is prepared from 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 low abnormal range.

Source page: https://510kreport.com/device/K021022
Methodology: https://510kreport.com/methodology