# K140198: Imdx HSV-1/2 for Abbott M2000

- Pathway: 510(k) (Traditional)
- Applicant: Intelligent Medical Devices, Inc.
- Decided: May 13, 2014 after 106 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
Longest line of descent: 2 generations back to K971662 (1997). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100336: Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711, Eragen Biosciences (2010) Summary page 2.

## Most influential descendants
- K172509: Sentosa SA201 HSV 1/2 Qualitative PCR Test (2018), 0 descendants of its own
- K142156: Seegene Anyplex II HSV-1/2 Assay (2015), 0 descendants of its own

## Indications for use
The lMDx HSV-l/2 for Abbott m2000 assay is an in vitro diagnostic test for the direct, qualitative detection and differentiation of herpes simplex virus type I (HSV-l) and type 2 (HSV-2) DNA from male and female skin lesions from anogenital or oral sites. The test is intended for use as an aid in the diagnosis of HSV infection in symptomatic patients. The assay is intended to be run on the Abbott m;2000 instrument system. Warning: The IMDx HSV 1/2 for Abbott m2000 assay is not FDA cleared for use with cerebrospinal fluid (CSF). The assay is not intended for prenatal screening.

Source page: https://510kreport.com/device/K140198
Methodology: https://510kreport.com/methodology