510(k) · Cleared
ClearedFidis TM Thyro, Model MX002
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biomedical Diagnostics (Bmd) SA · JZO System, Test, Thyroid Autoantibody
Cleared on Nov 21, 2006 as substantially equivalent to K905485 (General Biometrics, Inc., 1991) and 1 other predicate after a 148-day review. Its family tree reaches back 1 generation to 1991.
- Decided
- Nov 21, 2006
- Review
- 148 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K905486 (1991). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK905486 Immunowell Tpo (Microsome) TestGeneral Biometrics, Inc. · 1991
- This deviceK061794 Fidis TM Thyro, Model MX002Biomedical Diagnostics (Bmd) SA · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905486 | Immunowell Tpo (Microsome) Test | General Biometrics, Inc. | 1991 | — |
| 0 (this device) | K061794 | Fidis TM Thyro, Model MX002 | Biomedical Diagnostics (Bmd) SA | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JZO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JZO device
- #1 K250250 ADVIA Centaur Anti-Thyroid Peroxidase IIscore 10.5 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K905485 | Immunowell Thyroglobulin TestSummary page 1…biology Devices 3. Predicate Devices 510K Number Device Classification Name Manufacturer Name 1(905485IMMUNOWELL K905485 RIMMT OBULN THYROGLOBULIN TEST General Biometrics, INC… | 1991 |
| * | K905486 | Immunowell Tpo (Microsome) TestSummary page 1…1(905485IMMUNOWELL K905485 RIMMT OBULN THYROGLOBULIN TEST General Biometrics, INC K905486 IMMUNOWELL (MIC TPO OS E… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
How does its category compare?
All JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JZO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JZO
Too few JZO 510(k)s in any year since 2007 to give a median.
Recalls per year · JZO
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JZO
44in 2025
MAUDE reports naming product code JZO, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 2 | — | 0 | 8 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 35 |
| 2019 | 0 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 17 |
| 2021 | 0 | — | 0 | 19 |
| 2022 | 0 | — | 0 | 25 |
| 2023 | 2 | — | 0 | 33 |
| 2024 | 1 | — | 0 | 29 |
| 2025 | 1 | — | 1 | 44 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The FIDISTM THYRO kit is a semi-quantitative homogeneous fluorescent-based microparticles immunoassay using flow cytometry readings. It is designed for the detection of antibodies directed against thyroperoxydase (TPO) and thyroglobuline (TG).
Clinical utility:
The test system is used on serum samples as an aid in the diagnostic of auto-immune thyroid pathologies (Graves' disease and Hashimoto thryroiditis), in conjunction with clinical findings and other laboratory tests.
The FIDISTM THYRO kit is to be used on FIDISTM Analyser, software and washer.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061794 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061794: Fidis TM Thyro, Model MX002.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061794
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026