# K093815: Light Diagnostics Human Metapneumovirus Dfa Kit, Model Catalog Number 3124

- Pathway: 510(k) (Traditional)
- Applicant: Millipore Corporation
- Decided: Mar 12, 2010 after 88 days
- Product code: OMG (Antisera, Fluorescent, Human Metapneumovirus)
- Device class: 2
- Regulation: 21 CFR 866.3980
- 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) Validated RT-PCR method followed by hi-directional sequencing for confirmation and identification of Human Metapneumovirus: named in the summary without a submission number

## Indications for use
Light DiagnoSticS TM Human Metapneumovirus Direct Immuunoifluorescence Assay is intended for qualitative detection and identification of human metapneumovirus (hMPV) in direct respiratory specimen cell preparations from nasopharyngeal swab samples collected from patients with febrile respiratory illness. This assay detects but is not intended to differentiate the four recognized genetic sub-lineages of hMPV. Negative results do not preclude hMPV infection and should not be used as the sole basis for diagnosis, treatment or other managenient decisions. It is recommended that specimens found to be negative after examination of the direct specimen results be confirmed by FDA cleared hMPV molecular assay. For in vitro diagnostic use.

Source page: https://510kreport.com/device/K093815
Methodology: https://510kreport.com/methodology