El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3
FDA 510(k) K061376 · Theratest Laboratories, Inc.
510(k) numberK061376
Submission
- Device name
- El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3
- Applicant
- Theratest Laboratories, Inc.
Lombard, IL, US - Received
- May 17, 2006
- Decision date
- July 20, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code MOB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K161258 | NOVA Lite DAPI ANCA Ethanol Kit, NOVA Lite DAPI ANCA Formalin KitMOB · Traditional | Inova Diagnostics, Inc. | 02/03/2017SE |
| 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 |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K090753 | Theratest EL-ANTI-CCP/2NHX · Traditional | 03/05/2010SE |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | 09/03/2009SE |
| K071692 | Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test SystemsMVM · Traditional | 11/05/2007SE |
| K060176 | El-Acl Screen; El-Acl Igm, Igg, IgaMID · Special | 02/07/2006SE |
| K051066 | Theratest El-Ana ProfilesLKP · Traditional | 10/07/2005SE |
| K040291 | El-Ana Profiles: Anti-ChromatinLJM · Traditional | 03/11/2004SE |
| K024151 | El-Ana Profiles: Anti-Ribosomal Protein PMQA · Traditional | 02/06/2003SE |
| K024031 | The Theratest El-Ana Profiles: Anti-CentromereLJM · Traditional | 02/06/2003SE |
| K002559 | El-Ana PROFILES-2K1LJM · Traditional | 09/12/2000SE |
| K982622 | El-Ana Profiles: EL-ENA/5LLL · Traditional | 08/13/1998SE |
Questions and answers
When was El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3 cleared by the FDA?
El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3 (K061376) received a 510(k) decision of Substantially Equivalent on July 20, 2006, 64 days after the submission was received.
What is the product code of K061376?
The FDA product code is MOB – Test System, Antineutrophil Cytoplasmic Antibodies (Anca), a Class II (moderate risk) device regulated under 21 CFR 866.5660.