NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
FDA 510(k) K161258 · Inova Diagnostics, Inc.
510(k) numberK161258
Submission
- Device name
- NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit
- Applicant
- Inova Diagnostics, Inc.
San Diego, CA, US - Received
- May 4, 2016
- Decision date
- February 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
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|---|---|---|---|
| K261466 | Alegria Flash MPO; Alegria Flash PR3; Alegria Flash GBMMOB · Traditional | Zeus Scientific | 08/21/2026SE |
| K243776 | Anti-Neutrophil Cytoplasmic Antibodies (Ethanol-Fixed); Anti-Neutrophil Cytoplasmic…MOB · Traditional | Zeus Scientific | 05/07/2025SE |
| K172582 | EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic…MOB · Traditional | Euroimmun Us, Inc. | 05/24/2018SE |
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | Aesku.Diagnostics GmbH & Co. KG | 03/23/2018SE |
| K173792 | EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM ImmunoassayMOB · Traditional | Phadia AB | 03/13/2018SE |
| K140225 | Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/Gbm…MOB · Traditional | Phadia US, Inc. | 10/27/2014SE |
| K112545 | Quanta Flash PR3, Quanta Flash Mpo, Quanta Flash GBMMOB · Traditional | Inova Diagnostics, Inc. | 07/31/2012SE |
| K100917 | Fidis Vasculitis Assay Kit and Analyzer and Caris SystemMOB · Special | Biomedical Diagnostics (Bmd) SA | 11/03/2010SE |
| K092601 | Immulisa Anca Screen ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
| K092600 | Immulisa PR3 Antibody ElisaMOB · Traditional | Immco Diagnostics, Inc. | 10/07/2010SE |
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Questions and answers
When was NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit cleared by the FDA?
NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin Kit (K161258) received a 510(k) decision of Substantially Equivalent on February 3, 2017, 275 days after the submission was received.
What is the product code of K161258?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.