510(k) K180559
- Device
- HSV 1 & 2 ELITe MGB Kit; ELITe InGenius
- Applicant
- ELITechGroup
- 510(k) number
- K180559
- Product code
- PGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-29
- Date received
- 2018-03-01
- Regulation
- 866.3309
- Classification name
- Herpes Virus (vzv, Hsv1, Hsv2), Dna Detection Assay For Cutaneous And Mucocutaneous Lesion Samples
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Terry Trimingham
- Address
- 21720 23rd Dr. SE Suite 150 Bothell WA US 98021 98021
FDA Registration Numbers#
- 3011461582
- 3005360469
- 2023365
- 3019837962
- 2032839
- 3010749841
- 3003540236
- 3005248192
- 2024674
- 1524213
- 1528450
Source Documents#
Other 510(k) Records For Product Code PGI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233349 | Alinity m HSV 1 & 2 / VZV | Abbott Molecular, Inc. | 2024-05-03 |
| K232286 | Savanna HSV 1+2/VZV Assay, Savanna HSV 1+2/VZV Control Set, Savanna Instrument | Quidel Corporation | 2023-12-20 |
| K192376 | Simplexa VZV Swab Direct, Simplexa VZV Positive Control Pack | Diasorin Molecular, LLC | 2019-11-26 |
| K173798 | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack | Diasorin Molecular, LLC | 2018-03-14 |
| K162451 | Solana HSV 1+2/VZV Assay | Quidel Corporation | 2016-11-28 |
| K151906 | ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) | Luminex Corporation | 2015-10-06 |
| K151046 | illumigene HSV 1&2 DNA Amplification Assay, illumigene HSV 1&2 External Control Kit, illumipro-10 | Meridian Bioscience, Inc. | 2015-07-17 |
| DEN140004 | QUIDEL MOLECULAR DIRECT HSV 1 +2/VZV ASSAY | Diagnostic Hybrids, Inc. | 2014-05-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary