510(k) · Cleared
ClearedImmulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · JZO System, Test, Thyroid Autoantibody
Cleared on Jan 17, 1997 as substantially equivalent to K950090 (American Laboratory Products Co., Ltd., 1995) after a 123-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Jan 17, 1997
- Review
- 123 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K950090 (1995). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- This deviceK963695 Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozDiagnostic Products Corp. · 1997
- Descendant · cites it directly · 2 of its ownK991096 Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp. · 1999
- Descendant · 2 generations on · 1 of its ownK061382 Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models…Beckman Coulter, Inc. · 2006
- Descendant · 3 generations on · 0 of its ownK240469 Access TPO AntibodyBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 3 of 3 · See all- K991096Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp. · 1999 · cites it directly2descendants
- K061382Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227Beckman Coulter, Inc. · 2006 · 2 generations on1descendant
- K240469Access TPO AntibodyBeckman Coulter, Inc. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| 0 (this device) | 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 | — |
| +2 | K061382 | Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and… | Beckman Coulter, Inc. | 2006 | — |
| +3 | K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2006 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay)Summary page 1…ia 90045-5597 Establishment Registration Number: EURO/DPC: Not Applicable DPC: 2017183 Substantially Equivalent Predicate Device: =~ ORGenTec anti-TPO PIN Immuno Assay (K950090) Manufactured by ORGenTec, and distributed in the USA by ALPCO, Windham, NH Description of Device: IMMULITE Anti-TPO Ab is a cl… | 1995 |
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 |
|---|---|---|---|
| K991096 | Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06 | 1999 | 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?
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?
IMMULITE Anti-TPO Ab is a solid-phase, enzyme chemiluminescent immunoassay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of antibodies against thyroid peroxidase (TPO) in serum and EDTA plasma. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of thyroid diseases.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K963695 · printed Nov 6, 2026
Cite this page
510(k) Report. “K963695: Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K963695
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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