510(k) · Cleared
ClearedAccess Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227
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 Jul 6, 2006 as substantially equivalent to K991096 (Diagnostic Products Corp., 1999) after a 49-day review. Its family tree reaches back 3 generations to 1995. 1 later device descends from it.
- Decided
- Jul 6, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K950090 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- 2 generations backK963695 Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozDiagnostic Products Corp. · 1997
- 1 generation backK991096 Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp. · 1999
- This deviceK061382 Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models…Beckman Coulter, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK240469 Access TPO AntibodyBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240469Access TPO AntibodyBeckman Coulter, Inc. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| −2 | K963695 | Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz | Diagnostic Products Corp. | 1997 | — |
| −1 | K991096 | Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06 | Diagnostic Products Corp. | 1999 | — |
| 0 (this device) | K061382 | Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and… | Beckman Coulter, Inc. | 2006 | — |
| +1 | K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K991096 | Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Summary page 1…e Device * Immulite 2000 Anti-TPO Ab Diagnostic Products Corporation 5700 West 96 "~Street Los Angeles, CA 90045-5597 510(k) Number: k991096 Device Description The Access TPO Antibody reagents, calibrators, and the Access Immunoassay Analyzers (Access, A… | 1999 |
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 |
|---|---|---|---|
| K240469 | Access TPO Antibody | 2024 | 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 11 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240469 (Beckman Coulter, Inc., 2024) 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?
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 TPO antibodies is an aid in the diagnosis of thyroid autoimmune disorders.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061382 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061382: Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061382
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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