# K955812: Syscon Turmor Marker Control

- Pathway: 510(k) (Traditional)
- Applicant: Scantibodies Laboratory, Inc.
- Decided: Mar 12, 1996 after 77 days
- Product code: JJY (Multi-Analyte Controls, All Kinds (Assayed))
- Device class: 1
- Regulation: 21 CFR 862.1660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Dade Special-T™ Marker: named in the summary without a submission number

## Most influential descendants
- K990531: Vitros Immunodiagnostic Products Oncology Controls (1999), 0 descendants of its own

## Indications for use
For use as an assayed quality control material to assist in monitoring accuracy and precision in clinical immunoassays used in cancer antigen testing.

Source page: https://510kreport.com/device/K955812
Methodology: https://510kreport.com/methodology