# K974552: Diamedix IS-Measles Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Jan 28, 1998 after 55 days
- Product code: LJB (Enzyme Linked Immunoabsorbent Assay, Rubeola Igg)
- Device class: 1
- Regulation: 21 CFR 866.3520
- Recalls of this device: 1 (0 Class I)
- 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) Diamedix Measles IgG Microassay: named in the summary without a submission number

## Recalls of this device
- Oct 10, 2008 · Not classified · Z-0607-2009: Possible false-negative test results: The Sample A Diluent Lot # 50768 assigned to Is-Measles IgG Lot #'s 41108 and 41108B has higher conductivity than normal, which can sporadically interfere with th

## Indications for use
The Diamedix Is-Measles IgG test system is an Enzyme Immunoassay (EIA) for the semi-quantitative detection of IgG antibodies in human serum to measles virus as an aid in the assessment of the patient's immunological response to measles virus, to determine the immune status of individuals, and, when evaluating paired sera, as an aid in the diagnosis of measles infection.

Source page: https://510kreport.com/device/K974552
Methodology: https://510kreport.com/methodology