Thyroid Stimulating Immunoglobulin Reporter Assay
FDA 510(k) K083391 · Diagnostic Hybrids, Inc.
510(k) numberK083391
Submission
- Device name
- Thyroid Stimulating Immunoglobulin Reporter Assay
- Applicant
- Diagnostic Hybrids, Inc.
Athens, OH, US - Received
- November 17, 2008
- Decision date
- May 21, 2009
- 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
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|---|---|---|---|
| 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 |
| K080092 | Elecsys Anti-Tshr Immunoassay, Elecsys Precicontrol ThyroabJZO · Traditional | Roche Diagnostics Corp. | 07/28/2008SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
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| K092229 | Thyretain TM Tsi Reporter BioassayJZO · Traditional | 05/18/2010SE |
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| K092882 | D3 Fastpoint L-Dfa Influenza A/Influenza B Virus Identification KitGNW · Traditional | 10/21/2009SE |
| K091171 | D3 Ultra Duet Dfa Respiratory Virus Identification KitOMG · Traditional | 09/11/2009SE |
| K092300 | Modification to D3 Ultra Dfa Respiratory Virus Screening & Id KitGNW · Special | 08/28/2009SE |
| K091753 | Elvis HSV Id and D3 Typing Test SystemGQL · Traditional | 08/28/2009SE |
| K090073 | D3 Dfa Metapneumovirus Identification KitOMG · Traditional | 03/06/2009SE |
| K081928 | D3 Duet Dfa Rsv/Respiratory Virus Screening KitLKT · Traditional | 12/23/2008SE |
| K081746 | D3 Duet Dfa Influenza A/Respiratory Virus Screening KitGNW · Traditional | 12/23/2008SE |
Questions and answers
When was Thyroid Stimulating Immunoglobulin Reporter Assay cleared by the FDA?
Thyroid Stimulating Immunoglobulin Reporter Assay (K083391) received a 510(k) decision of Substantially Equivalent on May 21, 2009, 185 days after the submission was received.
What is the product code of K083391?
The FDA product code is JZO – System, Test, Thyroid Autoantibody, a Class II (moderate risk) device regulated under 21 CFR 866.5870.