# K982485: Seraquest CMV Igm

- Pathway: 510(k) (Traditional)
- Applicant: Quest Intl., Inc.
- Decided: Jan 13, 1999 after 180 days
- Product code: LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus)
- Device class: 2
- Regulation: 21 CFR 866.3175
- Recalls of this device: 2 (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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 19, 2022 · Class II · Z-0342-2023: Due to an unusual increase in the positivity rate with human IgM antibodies to cytomegalovirus (CMV) Enzyme Immunoassay (EIA).
- Sep 28, 2010 · Not classified · Z-0837-2012: Quest International recalled their CMV IgM Test kit because the device failed the test run due to lack of activity in the coated wells.

## Indications for use
1. For the qualitative detection of IgM antibodies to CMV in human serum by enzyme immunoassay, to aid in the diagnosis of CMV infection. 2. A positive result is presumptive for the detection of anti-CMV antibodies and presumptive for the diagnosis of acute or recent CMV infection. 3. Useful for the above indications, with specimens obtained from women of childbearing age. 4. For manual use, or for use with the HyPrep System Plus semi-automated fluid handler.

Source page: https://510kreport.com/device/K982485
Methodology: https://510kreport.com/methodology