510(k) K161258
- Device
- NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
- Applicant
- INOVA DIAGNOSTICS, INC.
- 510(k) number
- K161258
- Product code
- MOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-02-03
- Date received
- 2016-05-04
- Regulation
- 866.5660
- Classification name
- Test System, Antineutrophil Cytoplasmic Antibodies (anca)
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Gabriella Lakos
- Address
- 9900 Old Grove Rd. San Diego CA US 92131 92131
FDA Registration Numbers#
- 8043792
- 2242436
- 1421346
- 3003825930
- 3022178699
- 3032705
- 3002800697
- 3007361513
- 3039353646
- 3007208259
- 2029372
- 2245285
- 3003935253
- 1181121
- 2918768
- 3012348571
- 1318354
- 9610566
- 3015376545
- 2915274
- 2026994
- 3003268355
- 3004973408
- 3026753391
- 1181055
- 3007118747
Source Documents#
Other 510(k) Records For Product Code MOB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic Antibodies (Formalin-Fixed) | Zeus Scientific | 2025-05-07 |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic™ EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic™ EUROPattern | Euroimmun Us, Inc. | 2018-05-24 |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | Aesku.Diagnostics GmbH & Co. KG | 2018-03-23 |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay | Phadia AB | 2018-03-13 |
| K140225 | ELIA PR3S IMMUNOASSAY, ELIA MPOS IMMUNOASSAY, ELIA GBM IMMUNOASSAY, ELIA ANCA/GBM POSITIVE CONTROL 100, ELIA ANCA/GBM PO | Phadia US, Inc. | 2014-10-27 |
| K112545 | QUANTA FLASH PR3, QUANTA FLASH MPO, QUANTA FLASH GBM | Inova Diagnostics, Inc. | 2012-07-31 |
| K100917 | FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM | Biomedical Diagnostics (Bmd) SA | 2010-11-03 |
| K092600 | IMMULISA PR3 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 |
| K092599 | IMMULISA MPO ANTIBODY ELISA | Immco Diagnostics, Inc. | 2010-10-07 |
| K092601 | IMMULISA ANCA SCREEN ELISA | Immco Diagnostics, Inc. | 2010-10-07 |
| K091859 | AESKU PR3 | Aesku Diagnostics | 2010-06-03 |
| K091860 | AESKULISA MPO, MODEL 30-7303US | Aesku Diagnostics | 2010-02-23 |
| K083850 | EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS | Euroimmun Us, Inc. | 2009-05-20 |
| K082130 | EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) | Euroimmun Us, Inc. | 2009-04-07 |
| K070458 | MODIFICATION TO FIDIS VASCULITIS, MODEL MX007 | Biomedical Diagnostics (Bmd) SA | 2007-12-21 |
Legacy Summary#
summary
FDA Review#
Decision Summary