510(k) · Cleared
ClearedThyroid Stimulating Immunoglobulin Reporter Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Hybrids, Inc. · JZO System, Test, Thyroid Autoantibody
Cleared on May 21, 2009 as substantially equivalent to K032134 (Kronus Market Development Associates, Inc., 2003) after a 185-day review. Its family tree reaches back 1 generation to 2003. 2 later devices descend from it.
- Decided
- May 21, 2009
- Review
- 185 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K032134 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK032134 TSH Receptor Antibody (Trab) Coated Tube (CT) Assay KitKronus Market Development Associates, Inc. · 2003
- This deviceK083391 Thyroid Stimulating Immunoglobulin Reporter AssayDiagnostic Hybrids, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK092229 Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc. · 2010
- Descendant · 2 generations on · 0 of its ownK152061 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K032134 | TSH Receptor Antibody (Trab) Coated Tube (CT) Assay Kit | Kronus Market Development Associates, Inc. | 2003 | — |
| 0 (this device) | K083391 | Thyroid Stimulating Immunoglobulin Reporter Assay | Diagnostic Hybrids, Inc. | 2009 | — |
| +1 | K092229 | Thyretain TM Tsi Reporter Bioassay | Diagnostic Hybrids, Inc. | 2010 | — |
| +2 | K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2016 | 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? (1)
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 |
|---|---|---|---|
| * | K032134 | TSH Receptor Antibody (Trab) Coated Tube (CT) Assay KitSummary page 3…findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD). Legally marketed device to which equivalence is claimed: k032134 KRONUS TSH Receptor Antibody (TRAb) Coated Tube (CT) Assay Kit Intended Use: The KRONUS TSH Receptor Antibody (TRAb) Co… | 2003 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092229 | Thyretain TM Tsi Reporter Bioassay | 2010 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K092229 (Diagnostic Hybrids, Inc., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Thyretain TM TSI Reporter BioAssay is intended for the qualitative detection in serum of thyroid stimulating autoantibodies to the thyroid stimulating hormone (TSH) receptors (TSHRs) on the thyroid. The detection of these stimulating autoantibodies, in conjunction with other clinical and laboratory findings, may be useful as an aid in the differential diagnosis of patients with Graves' disease (GD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083391 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083391: Thyroid Stimulating Immunoglobulin Reporter Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083391
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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