# K944691: Itc Whole Blood Control  Normal/Abnormal Level I  or II

- Pathway: 510(k) (Traditional)
- Applicant: International Technidyne Corp.
- Decided: Mar 15, 1995 after 173 days
- Product code: GGN (Plasma, Coagulation Control)
- Device class: 2
- Regulation: 21 CFR 864.5425
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jul 8, 2010 · Not classified · Z-2108-2010: Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
- Jul 8, 2010 · Not classified · Z-2107-2010: Certain lots of GEM Check Coag Whole Blood Controls contain an error in the package insert where the incorrect Acceptable Performance Ranges were published.
- Jun 25, 2010 · Not classified · Z-2200-2010: The package insert for the directCheck Microcoagulation Quality Control contains an incorrect acceptable performance range regarding ACT-LR cuvettes
- Apr 15, 2010 · Not classified · Z-1786-2010: Indication not cleared or approved. The acceptable performance range published in the directCHECK Microcoagulation Quality Control package insert is incorrect.

Source page: https://510kreport.com/device/K944691
Methodology: https://510kreport.com/methodology