# K992829: Cascade Liquid Coagulation Control Levels 1, 2, and 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Nov 22, 1999 after 91 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
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
CASCADE™ Liquid Coagulation Control, Levels 1, 2, and 3 is a human plasma based quality control material intended for use in the clinical laboratory as a consistent test sample of known concentration for monitoring the performance of routine coagulation assays (prothrombin time, activated partial thromboplastin time, and fibrinogen assays). The user can compare recovered values with expected ranges as a means of assuring consistent performance of reagent and instrument. This product is for use on the MLA 1600 analyzer.

Source page: https://510kreport.com/device/K992829
Methodology: https://510kreport.com/methodology