# K023867: Mas T-Marker, Level 1,2 and 3, Dade Special-T Marker, Level 1,2 and 3

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Dec 17, 2002 after 27 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.
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. The FDA summary names no predicate by number.

## Indications for use
MAS@T-Marker Control is intended for use in the clinical laboratory as a quantitative control for monitoring test procedures used to assay human serum for tumor markers. Include T-Marker Control with patient serum specimens when assaying for any of the listed constituents Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument. DADE@Special-T Marker@Control is intended for use in the clinical laboratory as a quantitative control for monitoring test procedures used to assay human serum for tumor markers. Include Special-T Marker@Control with patient serum specimens when assaying for any of the listed constituents. Assay values are provided for the specific systems listed. The user can compare observations with expected ranges as a means of assuring consistent performance of reagent and instrument.

Source page: https://510kreport.com/device/K023867
Methodology: https://510kreport.com/methodology