# K103798: BD Probetec Herpes Simplex Viruses (HSV 1& 2) Q Amplified Dna Assays

- Pathway: 510(k) (Traditional)
- Applicant: Becton, Dickinson & CO
- Decided: Mar 18, 2011 after 81 days
- Product code: OQO (Herpes Simplex Virus Nucleic Acid Amplification Assay)
- 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.
2 later devices descend from it; 2 cite 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) ELVIS HSV ID and Typing Test System: named in the summary without a submission number

## Most influential descendants
- K162673: Aptima Herpes Simplex Viruses 1 & 2 Assay (2017), 0 descendants of its own
- K150617: cobas HSV 1 and 2 Test (2015), 0 descendants of its own

## Indications for use
The BD ProbeTecTM Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays, when tested with the BD ViperTM System in Extracted Mode, use Strand Displacement Amplification technology for the direct, qualitative detection and differentiation of Herpes Simplex virus type I (HSV1) and Herpes Simplex virus type 2 (HSV2) DNA in clinician-collected external anogenital lesion specimens. The assays are indicated for use with symptomatic individuals to aid in the diagnosis of anogenital HSV1 and HSV2 infections. Warning: The BD ProbeTecTM Herpes Simplex Viruses (HSV I & 2) QX Amplified DNA Assays (HSV QX Assays) are not FDA cleared for use with cerebrospinal fluid (CSF). The assays are not intended to be used for prenatal screening or for individuals under the age of 17 years.

Source page: https://510kreport.com/device/K103798
Methodology: https://510kreport.com/methodology