# K953839: Premier HSV Plus

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: May 23, 1996 after 281 days
- Product code: LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific)
- Device class: 2
- Regulation: 21 CFR 866.3305
- 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) Premier HSV: named in the summary without a submission number

## Indications for use
The Premier HSV is a qualitative enzyme immunoassay designed for detection of herpes simplex virus (HSV). The test is intended to be used for direct detection from genital or other skin vesicles/ulcerated lesions or asymptomatic genital specimens to rapidly confirm the presence of HSV. The test can also be used in conjunction with cell cultures inoculated with these specimens.

Source page: https://510kreport.com/device/K953839
Methodology: https://510kreport.com/methodology