# K063261: Nuclisens Easyq Enterovirus System

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 23, 2008 after 602 days
- Product code: OAI (Assay, Enterovirus Nucleic Acid)
- Device class: 2
- Regulation: 21 CFR 866.3225
- 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) Cell Culture for Enterovirus Detection [pre-amendment test method; no 510(k) applies]: named in the summary without a submission number

## Indications for use
The NucliSens EasyQ® Enterovirus v1.1 Assay is an in vitro nucleic acid amplification assay to be used in conjunction with the NucliSens EasyQ® System for the qualitative detection of Enterovirus RNA in cerebral spinal fluid (CSF) specimens in patients with signs and symptoms of meningitis. This test, in conjunction with other laboratory results and clinical information, may be used as an aid in the presumptive laboratory diagnosis of enterovirus infection in pediatric patients with a clinical suspicion of aseptic meningitis or aseptic meningioencephalitis. Negative results should be confirmed by cell culture. Assay performance characteristics have not been established for adults, or for immunocompromised or immunosuppressed patients. Caution: The results obtained with the NucliSens EasyQ Enterovirus v1.1 Assay should be used only as an adjunct to clinical observation and other information available to the physician. Positive results do not rule out other causes of meningitis, including bacteria, mycobacteria, other viruses (e.g. herpes family viruses, arboviruses, mumps virus, etc) and fungi.

Source page: https://510kreport.com/device/K063261
Methodology: https://510kreport.com/methodology