510(k) · Cleared
ClearedImmulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06
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 May 13, 1999 as substantially equivalent to K963695 (Diagnostic Products Corp., 1997) after a 42-day review. Its family tree reaches back 2 generations to 1995. 2 later devices descend from it.
- Decided
- May 13, 1999
- Review
- 42 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K950090 (1995). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK950090 Orgentec Anti-Tpo Pia (Pin Immuno Assay)American Laboratory Products Co., Ltd. · 1995
- 1 generation backK963695 Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozDiagnostic Products Corp. · 1997
- This deviceK991096 Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06Diagnostic Products Corp. · 1999
- Descendant · cites it directly · 1 of its ownK061382 Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models…Beckman Coulter, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK240469 Access TPO AntibodyBeckman Coulter, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K950090 | Orgentec Anti-Tpo Pia (Pin Immuno Assay) | American Laboratory Products Co., Ltd. | 1995 | — |
| −1 | K963695 | Immulite Anti-Tpo-AB (Lktoi,LKT05,Lktoz | Diagnostic Products Corp. | 1997 | — |
| 0 (this device) | 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 | — |
| +2 | K240469 | Access TPO Antibody | Beckman Coulter, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K963695 | Immulite Anti-Tpo-AB (Lktoi,LKT05,LktozSummary page 1…ice, 82-JZO (21CFR 866.5870) Diagnostic Products Corporation 5700 West 96" Street Los Angeles, CA 90045-5597 DPC Registration number 1s 2017183 IMMULITE" Anti-TPO Ab (K963695) IMMULITE® 2000 Anti-TPO Ab is a clinical use device intended for use with the IMMULITE® 2000 Automated Immunoassay Analyzer ==… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061382 | Access Tpo Antibody, and Access Tpo Antibody Calibrators, Models A12985 and A18227 | 2006 | 1 |
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 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K061382 (Beckman Coulter, Inc., 2006) has gone furthest, with 1 descendant 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?
IMMULITE 2000 Anti-TPO Ab is for in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative measurement of antithyroid peroxidase (TPO) antibodies in serum and EDTA plasma, 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/K991096 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991096: Immulite 2000 Anti-Tpo AB, Model L2KT02, L2KT06.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991096
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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