510(k) · Cleared
ClearedImdx HSV-1/2 for Abbott M2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Intelligent Medical Devices, Inc. · OQO Herpes Simplex Virus Nucleic Acid Amplification Assay
Cleared on May 13, 2014 as substantially equivalent to K100336 (Eragen Biosciences, 2010) after a 106-day review. Its family tree reaches back 2 generations to 1997. 2 later devices descend from it.
- Decided
- May 13, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- OQO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K971662 (1997). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK971662 Elvis HSV ID/Typing Test SystemDiagnostic Hybrids, Inc. · 1997
- 1 generation backK100336 Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Eragen Biosciences · 2010
- This deviceK140198 Imdx HSV-1/2 for Abbott M2000Intelligent Medical Devices, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK172509 Sentosa SA201 HSV 1/2 Qualitative PCR TestVela Diagnostics USA, Inc. · 2018
- Descendant · cites it directly · 0 of its ownK142156 Seegene Anyplex II HSV-1/2 AssaySeegene · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971662 | Elvis HSV ID/Typing Test System | Diagnostic Hybrids, Inc. | 1997 | — |
| −1 | K100336 | Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711 | Eragen Biosciences | 2010 | — |
| 0 (this device) | K140198 | Imdx HSV-1/2 for Abbott M2000 | Intelligent Medical Devices, Inc. | 2014 | — |
| +1 | K172509 | Sentosa SA201 HSV 1/2 Qualitative PCR Test | Vela Diagnostics USA, Inc. | 2018 | — |
| +1 | K142156 | Seegene Anyplex II HSV-1/2 Assay | Seegene | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OQO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K100336 | Multicode - RTX Herpes Simplex Virus 1 and 2 Kit, Model 3711Summary page 2…s. Substantial Equivalency The IM~x HSV-1/2 for Abbott mn2000 is substantially equivalent to the Eragen Bioscience, Inc MultiCodJ'-R Fx Herpes Simplex Virus I & 2 Kit. (K 100336). Table I compares the characteristics of the IM~x H-SV-1/2 for Abbott mn2000 assay (New Device) and the MultiCode'-RTx Herpes Si… | 2010 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 12.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K172509 (Vela Diagnostics USA, Inc., 2018) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K100336.
How does its category compare?
All OQO devicesOQO Herpes Simplex Virus Nucleic Acid Amplification Assay: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OQO
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OQO
140in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OQO
No recall names OQO since 2007.
Adverse event reports per year · OQO
1in 2025
MAUDE reports naming product code OQO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 3 | 81 | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 3 | 87 | 0 | 0 |
| 2015 | 3 | 140 | 0 | 0 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K140198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140198: Imdx HSV-1/2 for Abbott M2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140198
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026