Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test Systems
FDA 510(k) K071692 · Theratest Laboratories, Inc.
510(k) numberK071692
Submission
- Device name
- Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test Systems
- Applicant
- Theratest Laboratories, Inc.
Lombard, IL, US - Received
- June 20, 2007
- Decision date
- November 5, 2007
- 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 |
| K181871 | EliA Celikey IgG Immunoassay; EliA GliadinDP IgA Immunoassay; EliA GliadinDP IgG…MVM · Traditional | Phadia AB | 03/01/2019SE |
| 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 |
More from Grifols USA, 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 |
| K061376 | El-Anca: Anti-Mpo, ANTI-PR3, Anti-Mpo and ANTI-PR3MOB · Traditional | 07/20/2006SE |
| 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 Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test Systems cleared by the FDA?
Theratest El-Ttg Iga/Igg and Theratest El-Glia Iga/Igg Test Systems (K071692) received a 510(k) decision of Substantially Equivalent on November 5, 2007, 138 days after the submission was received.
What is the product code of K071692?
The FDA product code is MVM – Autoantibodies, Endomysial(Tissue Transglutaminase), a Class II (moderate risk) device regulated under 21 CFR 866.5660.