510(k) · Cleared
Recalled · Class II · 2025Architect Anti-Tpo Immunoassay, Calibrators & Controls
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher Diagnostics · JZO System, Test, Thyroid Autoantibody
Cleared on Jul 18, 2006 as substantially equivalent to K020348 (Axis-Shield Diagnostics, Ltd., 2002) after a 320-day review. Its family tree reaches back 1 generation to 2002. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Jul 18, 2006
- Review
- 320 days
- Class
- Class II
- Product code
- JZO
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K020348 (2002). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK020348 Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising…Axis-Shield Diagnostics, Ltd. · 2002
- This deviceK052407 Architect Anti-Tpo Immunoassay, Calibrators & ControlsFisher Diagnostics · 2006
- Descendant · cites it directly · 0 of its ownK250250 ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K250250ADVIA Centaur Anti-Thyroid Peroxidase IISiemens Healthcare Diagnostics, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K020348 | Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising… | Axis-Shield Diagnostics, Ltd. | 2002 | — |
| 0 (this device) | K052407 | Architect Anti-Tpo Immunoassay, Calibrators & Controls | Fisher Diagnostics | 2006 | — |
| +1 | K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | Siemens Healthcare Diagnostics, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K020348 | Abbott Axsym Anti-Thyroid-Peroxidase, MODELS5F57 Comprising Standards/CalibratorsSummary page 1…JIT Identification of Predicate Device: Abbott AxSYM® anti-Thyroid peroxidase (Anti-TPO) Microparticle Enzyme Immunoassay (MEIA) (K020348) Intended Use of the Device: ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (… | 2002 |
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 |
|---|---|---|---|
| K250250 | ADVIA Centaur Anti-Thyroid Peroxidase II | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 24, 2025 | Class II | Z-1843-2025 | Storage | transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test… |
| Apr 24, 2023 | Class III | Z-1696-2023 | Nonconforming Material/Component | Due to a manufacturing fill volume error, Alinity i Anti-TPO Reagent contains a marginally lower fill volume than detailed in the Kit Contents section of the Instructions for Use (IFU). |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K250250 (Siemens Healthcare Diagnostics, Inc., 2025) 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.
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?
ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® i System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease. The ARCHITECT® Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for…
Read the full statement (132 words)
ARCHITECT® Anti-TPO is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma (EDTA and Heparin) on the ARCHITECT® i System. The ARCHITECT® Anti-TPO assay is intended for use as an aid in the diagnosis of autoimmune thyroid disease.
The ARCHITECT® Anti-TPO Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
The ARCHITECT® Anti-TPO Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT® i System (reagents, calibrators and instrument), when used for the quantitative determination of the IgG class of thyroid peroxidase autoantibodies (anti-TPO) in human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052407 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052407: Architect Anti-Tpo Immunoassay, Calibrators & Controls.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052407
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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