# K023307: Mas Diabetes Control - Lyophilized Assayed Diabetes Control

- Pathway: 510(k) (Traditional)
- Applicant: Medical Analysis Systems, Inc.
- Decided: Oct 31, 2002 after 28 days
- Product code: JJX (Single (Specified) Analyte Controls (Assayed And Unassayed))
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K040025: A1C-Cellular (2004), 0 descendants of its own

## Indications for use
MAS Diabetes Control is intended for use in the clinical laboratory as an assayed control material suitable for monitoring assay conditions for glycated hemoglobin determinations. Include with patient specimens when assaying for glycated hemoglobin. 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/K023307
Methodology: https://510kreport.com/methodology