EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
FDA 510(k) K181871 · Phadia AB
510(k) numberK181871
Submission
- Device name
- EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay
- Applicant
- Phadia AB
Uppsala, SE - Received
- July 12, 2018
- Decision date
- March 1, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVM – Autoantibodies, Endomysial(Tissue Transglutaminase)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5660
- Specialty
- Immunology
Other 510(k)s with product code MVM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K200230 | Aptiva Celiac Disease IgG ReagentMVM · Traditional | Inova Diagnostics, Inc. | 08/26/2021SE |
| K193604 | Aptiva Celiac Disease IgA ReagentMVM · Traditional | Inova Diagnostics, Inc. | 06/16/2021SE |
| K183313 | EUROIMMUN Anti-tissue Transglutaminase ELISA (IgA), EUROIMMUN Anti-tissue…MVM · Traditional | Euroimmun Us, Inc. | 02/28/2019SE |
| K140691 | Ig_Plex Celiac DGP PanelMVM · Traditional | Sqi Diagnostics Systems, Inc. | 11/06/2014SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | Immco Diagnostics, Inc. | 10/25/2013SE |
| K130053 | Bioplex 2200 Celiac Iga and Igg Kits on the Bioplex 2200 System, Bioplex 2200 Celiac Iga…MVM · Traditional | Bio-Rad Laboratories, Inc. | 09/19/2013SE |
| K102490 | Igx Plex Celiac Qualitative AssayMVM · Traditional | Sqi Diagnostics Systems | 06/02/2011SE |
| K101644 | Quanta Flash H-Ttg IggMVM · Traditional | Inova Diagnostics, Inc. | 03/23/2011SE |
| K102964 | Eu-Ttg Iga and Eu-Ttg IggMVM · Traditional | Grifols USA, Inc. | 03/07/2011SE |
| K094060 | Quanta Flash H-Ttg IgaMVM · Traditional | Inova Diagnostics, Inc. | 10/13/2010SE |
More from Inova Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253367 | EliA CTD 13 ScreenLLL · Traditional | 06/25/2026SE |
| K212181 | ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen…DHB · Traditional | 08/03/2022SE |
| K210902 | EliA Ro52, EliA Ro60LKJ · Traditional | 07/27/2022SE |
| K202541 | EliA RNA Pol IIINYO · Traditional | 09/13/2021SE |
| K202540 | EliA Rib-PMQA · Traditional | 09/13/2021SE |
| K202067 | EliA SmDP-SLKP · Traditional | 07/14/2021SE |
| K200279 | ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal(alpha-Gal) Thyroglobulin, bovineDHB · Traditional | 05/01/2020SE |
| K190710 | EliA SymphonyS ImmunoassayLLL · Traditional | 11/29/2019SE |
| K190315 | ImmunoCAP Allergen e229, Allergen Component rCan f 4 Dog, ImmunoCAP Allergen e230…DHB · Traditional | 05/14/2019SE |
| K183007 | EliA SmDP ImmunoassayLKP · Traditional | 12/24/2018SE |
Questions and answers
When was EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay cleared by the FDA?
EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG Immunoassay (K181871) received a 510(k) decision of Substantially Equivalent on March 1, 2019, 232 days after the submission was received.
What is the product code of K181871?
The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.