# K022046: Vital Scientific Coagulation Control,Coagulation Control Level 1,2,3,Quikcoag Coagulation Control

- Pathway: 510(k) (Traditional)
- Applicant: Vital Scientific N.V.
- Decided: Jul 23, 2002 after 29 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: 1 generation back to K931117 (1994). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952622: Cryo Check Normal Human Reference Plasma, Precision Biologicals, Inc. (1995). Our reading of the summary gave K952662, FDA’s number for Comp=Flow (Jeneric/Pentron, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Precision Biologic Pooled Normal Plasma”.
- K931117: Assess (TM) Low Abnormal Control, Instrumentation Laboratory CO (1994) Summary page 2.
- K931118: Assess (TM) High Abnormal Control, Instrumentation Laboratory CO (1994) Summary page 2.

## Indications for use
The Coagulation Controls Levels 1, 2, and 3 are in-vitro diagnostic reagents intended for clinical use as a control to monitor the performance of coagulation testing of Prothrombin Time (PT) and activated Partial Thromboplastin time (APPT). Level Iyields result in the normal range. Level 2 yields results in the moderately abnormal range. Level 3 is intended to yield results in the extremely abnormal range.

Source page: https://510kreport.com/device/K022046
Methodology: https://510kreport.com/methodology