510(k) · Cleared
ClearedTSH Receptor Antibody (Trab) Coated Tube (CT) Assay Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kronus Market Development Associates, Inc. · JZO System, Test, Thyroid Autoantibody
Cleared on Sep 10, 2003 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it.
- Decided
- Sep 10, 2003
- Review
- 61 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK032134 TSH Receptor Antibody (Trab) Coated Tube (CT) Assay KitKronus Market Development Associates, Inc. · 2003
- Descendant · cites it directly · 2 of its ownK083391 Thyroid Stimulating Immunoglobulin Reporter AssayDiagnostic Hybrids, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK092229 Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc. · 2010
- Descendant · 3 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 3 of 3 · See all- K083391Thyroid Stimulating Immunoglobulin Reporter AssayDiagnostic Hybrids, Inc. · 2009 · cites it directly2descendants
- K092229Thyretain TM Tsi Reporter BioassayDiagnostic Hybrids, Inc. · 2010 · 2 generations on1descendant
- K152061IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification MaterialSiemens Healthcare Diagnostics, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K092229 | Thyretain TM Tsi Reporter Bioassay | Diagnostic Hybrids, Inc. | 2010 | — |
| +3 | 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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083391 | Thyroid Stimulating Immunoglobulin Reporter Assay | 2009 | 2 |
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?
- Of its descendants, K083391 (Diagnostic Hybrids, Inc., 2009) has gone furthest, with 2 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.
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 TRab CT Assay Kit is for the quantitative or qualitative determination of thyroid stimulating hormone receptor antibody in human serum.
The TRab CT Assay kit is iisehl as an aid in differential diagnosis of Graves’ disease.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K032134 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032134: TSH Receptor Antibody (Trab) Coated Tube (CT) Assay Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032134
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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