510(k) · Cleared
ClearedAccess TPO Antibody
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JZO System, Test, Thyroid Autoantibody
Cleared on Aug 9, 2024 as substantially equivalent to K061382 (Beckman Coulter, Inc., 2006) after a 171-day review. Its family tree reaches back 4 generations to 1995.
- Decided
- Aug 9, 2024
- Review
- 171 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K950090 (1995). No later device cites it as a predicate yet.
- Root · 4 generations backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- 3 generations backK963695 Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozDiagnostic Products Corp. · 1997
- 2 generations backK991096 Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp. · 1999
- 1 generation backK061382 Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models…Beckman Coulter, Inc. · 2006
- This deviceK240469 Access TPO AntibodyBeckman Coulter, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| −3 | K963695 | Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz | Diagnostic Products Corp. | 1997 | — |
| −2 | K991096 | Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06 | Diagnostic Products Corp. | 1999 | — |
| −1 | K061382 | Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and… | Beckman Coulter, Inc. | 2006 | — |
| 0 (this device) | K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024 | — |
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 |
|---|---|---|---|
| * | K061382 | Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227Summary page 4…oassay Analyzer Classification Name: Thyroid Autoantibody Classification Regulation: [21 CFR 866.5870] Predicate Device Device Name: Access TPO Antibody 510(k) Numbers: k061382 Device Description The Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitativ… | 2006 |
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?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 7.1 years on median.
- None of the 4 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. 2024, 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 Access TPO Antibody assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroperoxidase antibody (TPOAb) levels in human serum and plasma using the Access Immunoassay Systems.
The detection of TPOAb is an aid in the diagnosis of thyroid autoimmune disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240469 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240469: Access TPO Antibody.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240469
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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