Architect Anti-Tpo Immunoassay, Calibrators & Controls
FDA 510(k) K052407 · Fisher Diagnostics
510(k) numberK052407
Submission
- Device name
- Architect Anti-Tpo Immunoassay, Calibrators & Controls
- Applicant
- Fisher Diagnostics
Middletown, VA, US - Received
- September 1, 2005
- Decision date
- July 18, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JZO – System, Test, Thyroid Autoantibody
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5870
- Specialty
- Immunology
Other 510(k)s with product code JZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase IIJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/17/2025SE |
| K240469 | Access TPO AntibodyJZO · Traditional | Beckman Coulter, Inc. | 08/09/2024SE |
| K213517 | Access Thyroglobulin Antibody IIJZO · Traditional | Beckman Coulter, Inc. | 09/26/2023SE |
| K222610 | Elecsys Anti-TgJZO · Traditional | Roche Diagnostics | 09/15/2023SE |
| K193313 | Elecsys Anti-TSHRJZO · Traditional | Roche Diagnostics | 02/27/2020SE |
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…JZO · Traditional | Phadia AB | 03/25/2016SE |
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialJZO · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/03/2016SE |
| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/18/2010SE |
| K090760 | Theratest El-Anti-Tpo and Theratest El-Anti-Thyroglobulin, Model 104-119, 103-120JZO · Traditional | Theratest Laboratories, Inc. | 09/03/2009SE |
| K083391 | Thyroid Stimulating Immunoglobulin Reporter AssayJZO · Traditional | Diagnostic Hybrids, Inc. | 05/21/2009SE |
More from Diagnostic Hybrids, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K170652 | ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S…PRI · Traditional | 06/01/2017SE |
| K070640 | Architect Stat TROPONIN-1; MyoglobinMMI · Special | 09/13/2007SE |
| K052308 | Architect Anti-Tg Immunoassay Reagents, Calibrators, Controls and System Assay Cd-RomJZO · Traditional | 05/10/2006SE |
| K042924 | Architect Stat Myo ImmunoassayDDR · Traditional | 01/24/2005SE |
| K041192 | Architect Stat Troponin-I ImmunoassayMMI · Traditional | 08/12/2004SE |
| K041596 | Architect Stat Ck-Mb ImmunoassayJHX · Traditional | 07/21/2004SE |
| K023362 | Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus KaolinGKP · Traditional | 12/09/2002SE |
| K013397 | Pacific Hemostasis Reference EmulsionJIX · Traditional | 02/15/2002SE |
| K010750 | Pacific Hemostasis Inr Control Plasmas, Model Catalog 100560GGN · Traditional | 09/07/2001SE |
| K850160 | Fisher Diagnostics Latest-Crp Test KitDCK · Traditional | 04/19/1985SE |
Questions and answers
When was Architect Anti-Tpo Immunoassay, Calibrators & Controls cleared by the FDA?
Architect Anti-Tpo Immunoassay, Calibrators & Controls (K052407) received a 510(k) decision of Substantially Equivalent on July 18, 2006, 320 days after the submission was received.
What is the product code of K052407?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.