# K093101: MAGO 4S

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Jan 21, 2011 after 477 days
- Product code: LFX (Enzyme Linked Immunoabsorbent Assay, Rubella)
- Device class: 2
- Regulation: 21 CFR 866.3510
- 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 its predicate without a number.
- (no number) PhD System, Bio-Rad Laboratories: named in the summary without a submission number

## Indications for use
For the qualitative, semi-quantitative and quantitative detection of IgG antibodies to rubella in human serum by indirect enzyme immunoassay to aid in the assessment of the patient's immunological response to rubella and in The determination of the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of current or recent infection with rubella. The Mago 4S Automated EJA and IFA Processor is a pipetting, diluting, incubating, and color intensity analyzing system for in vitro diagnostic clinical use for the processing of FDA-cleared enzyme-linked immunoabsorbent assays (EIA) through result generation. In addition, it processes immunofluorescence assay (IFA) slides for off-platform detection and result generation.

Source page: https://510kreport.com/device/K093101
Methodology: https://510kreport.com/methodology