510(k) · Cleared
ClearedVarelisa Tpo Antibodies, Model 12348/12396
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmacia & Upjohn Co. · JZO System, Test, Thyroid Autoantibody
Cleared on Jan 5, 2000 after a 75-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 5, 2000
- Review
- 75 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993585 Varelisa Tpo Antibodies, Model 12348/12396Pharmacia & Upjohn Co. · 2000
- Descendant · cites it directly · 0 of its ownK151799 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid…Phadia AB · 2016
Most influential descendants
Showing 1 of 1 · See all- K151799EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250…Phadia AB · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993585 | Varelisa Tpo Antibodies, Model 12348/12396 | Pharmacia & Upjohn Co. | 2000 | — |
| +1 | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive… | Phadia AB | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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 |
|---|---|---|---|
| * | — | elias™ TM Antibodies Named without a submission number |
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 |
|---|---|---|---|
| K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250… | 2016 | 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?
- Of its descendants, K151799 (Phadia AB, 2016) 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 Varelisa TPO Antibodies EIA kit is designed for the quantitative and qualitative determination of TPO (thyroid peroxidase) antibodies in serum or plasma to aid in the diagnosis of thyroid diseases such as Autoimmune Thyroiditis and Graves’ Disease.
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/K993585 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993585: Varelisa Tpo Antibodies, Model 12348/12396.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993585
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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