# K981163: Diamedix IS-CMV Igg Test System

- Pathway: 510(k) (Traditional)
- Applicant: Diamedix Corp.
- Decided: Sep 21, 1998 after 174 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- 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.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Incstar CMV IgG ELISA Kit: named in the summary without a submission number

## Most influential descendants
- K131605: Elecsys Precicontrol CMV Igg, Elecsys CMV Igg Immunoassay (2014), 1 descendant of its own
- K220911: Elecsys CMV IgG (2022), 0 descendants of its own

## Recalls of this device
- Mar 26, 2015 · Class II · Z-1689-2016: Product contained an incorrect substrate.

## Indications for use
The Diamedix Is-CMV I9G an Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies in human serum by EIA to aid in the assessment of the patient's immunological response to CMV and to determine the immune status of individuals, including females of child-bearing age. The evaluation of acute and convalescent sera can aid in the diagnosis of primary infection, reactivated infection, or reinfection with CMV. These reagents can be used either manually or in conjunction with the MAGO® Plus Aulomated EIA Processor.

Source page: https://510kreport.com/device/K981163
Methodology: https://510kreport.com/methodology