510(k) · Cleared
ClearedArchitect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-Rom
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 May 10, 2006 as substantially equivalent to K983992 (Nichols Institute Diagnostics, 1999) and 1 other predicate after a 259-day review. Its family tree reaches back 1 generation to 1997.
- Decided
- May 10, 2006
- Review
- 259 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K972070 (1997). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK972070 Nichols Advantage Chemiluminescence Tri-Level Specialty ControlsNichols Institute Diagnostics · 1997
- This deviceK052308 Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and…Fisher Diagnostics · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972070 | Nichols Advantage Chemiluminescence Tri-Level Specialty Controls | Nichols Institute Diagnostics | 1997 | — |
| 0 (this device) | K052308 | Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay… | Fisher Diagnostics | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 |
|---|---|---|---|
| * | K983992 | Nichols Advantage Thyroglobulin Autoantibodies (Tgab) AssaySummary page 1…862.1150 FDA Panel: Immunology, Clinical Chemistry Product Code: JZO, JJX, JIT Identification of Predicate Device: Nichols Advantage Thyroglobulin Autoantibodies Assay (K983992) Nichols Advantage Chemiluminescence Tri-Level Controls (K972070) Intended Use of the Device: ARCHITECT® Anti-Tg is a Chemilumin… | 1999 |
| * | K972070 | Nichols Advantage Chemiluminescence Tri-Level Specialty ControlsSummary page 1…JZO, JJX, JIT Identification of Predicate Device: Nichols Advantage Thyroglobulin Autoantibodies Assay (K983992) Nichols Advantage Chemiluminescence Tri-Level Controls (K972070) Intended Use of the Device: ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative dete… | 1997 |
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?
ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease. The ARCHITECT® Anti-Tg Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG…
Read the full statement (124 words)
ARCHITECT® Anti-Tg is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of the IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma on the ARCHITECT i System. The ARCHITECT Anti-Tg assay is intended for use as an aid in the diagnosis of thyroid disease.
The ARCHITECT® Anti-Tg Calibrators are for the calibration of the ARCHITECT® i System when used for the quantitative determination of IgG class of thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
The ARCHITECT® Anti-Tg 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 thyroglobulin autoantibodies (anti-Tg) in human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052308 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052308: Architect Anti-TG Immunoassay Reagents, Calibrators, Controls and System Assay CD-Rom.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052308
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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