510(k) · Cleared
ClearedEliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia AB · JZO System, Test, Thyroid Autoantibody
Cleared on Mar 25, 2016 as substantially equivalent to K003414 (Pharmacia & Upjohn Co., 2000) and 3 other predicates after a 267-day review. Its family tree reaches back 2 generations to 2002.
- Decided
- Mar 25, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- JZO
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K023285 (2002). 9 ancestors in all, the oldest K993585 (2000). No later device cites it as a predicate yet.
- Root · 2 generations backK023285 Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) ElisaAxis-Shield Diagnostics, Ltd. · 2002 · Recalled
- 1 generation backK061165 Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Sweden Diagnostics (Us), Inc. · 2006 · Recalled
- This deviceK151799 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid…Phadia AB · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K023285 | Diastat Anti Cyclic Citrullinated Peptide (Anti-CCP) Elisa | Axis-Shield Diagnostics, Ltd. | 2002 | 1 |
| −1 | K061165 | Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01 | Sweden Diagnostics (Us), Inc. | 2006 | 1 |
| 0 (this device) | K151799 | EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive… | Phadia AB | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2004 | 2 | 0 |
| 2010 | 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? (4)
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 |
|---|---|---|---|
| * | K003414 | Varelisa TG (Thyroglobulin) Antibodies,Summary page 8…ti-TPO test. J. Substantial Equivalence Information: 1. Predicate device name(s) and 510(k) number(s): VarelisA TG Antibodies, Phadia GmbH K003414 VarelisA TPO Antibodies, Phadia GmbH K993585 EliA™ IgG/IgM/IgA Negative Control 250 K… | 2000 |
| * | K993585 | Varelisa Tpo Antibodies, Model 12348/12396Summary page 8…cate device name(s) and 510(k) number(s): VarelisA TG Antibodies, Phadia GmbH K003414 VarelisA TPO Antibodies, Phadia GmbH K993585 EliA™ IgG/IgM/IgA Negative Control 250 K091845 EliA IgG Calibrator Strips K… | 2000 |
| * | K091845 | Cardiolipin Autoantibody Immunological Test SystemSummary page 8…s, Phadia GmbH K003414 VarelisA TPO Antibodies, Phadia GmbH K993585 EliA™ IgG/IgM/IgA Negative Control 250 K091845 EliA IgG Calibrator Strips K061165 Supplement to Trad. 510(k) submission for Eli… | 2010 |
| * | K061165 | Elia CCP, Model 14-5515-01; Elia CCP Control, Model 83-1009-01Summary page 8…es, Phadia GmbH K993585 EliA™ IgG/IgM/IgA Negative Control 250 K091845 EliA IgG Calibrator Strips K061165 Supplement to Trad. 510(k) submission for EliA Thyroid 035_F.1 510k Decision Summary Input - V4… | 2006 |
What descends from it?
No later submission names this one as a predicate yet.
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 14 years and passes through 3 companies; a new generation was cleared every 9.6 years on median.
- 3 of the 9 ancestors have a recall of any class.
How does its category compare?
All JZO devicesJZO System, Test, Thyroid Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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?
EliA anti-TG Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroglobulin (TG) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TG uses the EliA IgG method on the instrument Phadia 250. EliA anti-TG Immunoassay is intended for the in vitro quantitative…
Read the full statement (304 words)
EliA anti-TG Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroglobulin (TG) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TG uses the EliA IgG method on the instrument Phadia 250.
EliA anti-TG Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroglobulin (TG) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TG uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA anti-TPO Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroid peroxidase (TPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TPO uses the EliA IgG method on the instrument Phadia 250.
EliA anti-TPO Immunoassay is intended for the in vitro quantitative measurement of IgG antibodies directed to thyroid peroxidase (TPO) in human serum and plasma (Li-heparin, EDTA) as an aid in the clinical diagnosis of autoimmune thyroiditis and Graves' disease in conjunction with other laboratory and clinical findings. EliA anti-TPO uses the EliA IgG method on the instrument Phadia 2500/5000.
EliA Thyroid Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies against thyroid peroxidase (TPO) and thyroglobulin (TG) with Phadia 250 using the EliA IgG method.
EliA Thyroid Positive Control 2500/5000 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies against thyroid peroxidase (TPO) and thyroglobulin (TG) with Phadia 2500/5000 using the EliA IgG method.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151799 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151799: EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151799
Report an extraction error
Are you the manufacturer?
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