510(k) · Cleared
ClearedOrgentec Anti-Tpo Pia (Pin Immuno Assay)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
American Laboratory Products Co., Ltd. · JZO System, Test, Thyroid Autoantibody
Cleared on Apr 21, 1995 after a 101-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Apr 21, 1995
- Review
- 101 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- Descendant · cites it directly · 4 of its ownK980206 Immulite Anti-TG ABDiagnostic Products Corp. · 1998
- Descendant · 2 generations on · 3 of its ownK991094 Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp. · 1999 · Recalled
- Descendant · cites it directly · 3 of its ownK963695 Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozDiagnostic Products Corp. · 1997
- Descendant · 3 generations on · 2 of its ownK020672 Elecsys Anti-TG Test SystemRoche Diagnostics Corp. · 2002
- Descendant · 2 generations on · 2 of its ownK991096 Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp. · 1999
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K980206Immulite Anti-TG ABDiagnostic Products Corp. · 1998 · cites it directly4descendants
- K991094Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6Diagnostic Products Corp. · 1999 · 2 generations on3descendants
- K963695Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozDiagnostic Products Corp. · 1997 · cites it directly3descendants
- K020672Elecsys Anti-TG Test SystemRoche Diagnostics Corp. · 2002 · 3 generations on2descendants
- K991096Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp. · 1999 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| +1 | K980206 | Immulite Anti-TG AB | Diagnostic Products Corp. | 1998 | — |
| +2 | K991094 | Immulite 2000 Anti-TG AB, Model L2KTG2, L2KTG6 | Diagnostic Products Corp. | 1999 | 2 |
| +1 | K963695 | Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz | Diagnostic Products Corp. | 1997 | — |
| +3 | K020672 | Elecsys Anti-TG Test System | Roche Diagnostics Corp. | 2002 | — |
| +2 | K991096 | Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06 | Diagnostic Products Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2006 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K980206 (Diagnostic Products Corp., 1998) has gone furthest, with 4 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 | — |
https://510kreport.com/device/K950090 · printed Nov 6, 2026
Cite this page
510(k) Report. “K950090: Orgentec Anti-Tpo Pia (Pin Immuno Assay).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950090
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026