510(k) · Cleared
ClearedThyretain TM Tsi Reporter Bioassay
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 18, 2010 as substantially equivalent to K083391 (Diagnostic Hybrids, Inc., 2009) after a 299-day review. Its family tree reaches back 2 generations to 2003. 1 later device descends from it.
- Decided
- May 18, 2010
- Review
- 299 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K032134 (2003). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK032134 TSH Receptor Antibody (Trab) Coated Tube (CT) Assay KitKronus Market Development Associates, Inc. · 2003
- 1 generation backK083391 Thyroid Stimulating Immunoglobulin Reporter AssayDiagnostic Hybrids, Inc. · 2009
- This deviceK092229 Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK152061 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification…Siemens Healthcare Diagnostics, Inc. · 2016 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K032134 | TSH Receptor Antibody (Trab) Coated Tube (CT) Assay Kit | Kronus Market Development Associates, Inc. | 2003 | — |
| −1 | K083391 | Thyroid Stimulating Immunoglobulin Reporter Assay | Diagnostic Hybrids, Inc. | 2009 | — |
| 0 (this device) | K092229 | Thyretain TM Tsi Reporter Bioassay | Diagnostic Hybrids, Inc. | 2010 | — |
| +1 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K083391 | Thyroid Stimulating Immunoglobulin Reporter AssaySummary page 1…JZO Regulation: 21 CFR § 866.5870, Thyroid Autoantibody Inmmunological Test LEGALLY MARKETED DEVICE Thyretain Tm TSI Reporter BioAssay (TSI Reporter), K083391 DESCRIPTION of DEVICE MODIFICATION The number of wells tested per Positive, Reference and Negative control has been… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152061 | IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material | 2016 | 0 |
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?
- The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K152061 (Siemens Healthcare Diagnostics, Inc., 2016) has gone furthest, with 0 descendants 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. 2010, 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 (TSHIRs) 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/K092229 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092229: Thyretain TM Tsi Reporter Bioassay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092229
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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