510(k) · Cleared
ClearedImmunocap Thyrlobulin Immunocap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phadia US, Inc. · JNL Immunochemical, Thyroglobulin Autoantibody
Cleared on Nov 20, 2007 as substantially equivalent to K981559 (Pharmacia & Upjohn Co., 1998) and 1 other predicate after a 60-day review. Its family tree reaches back 1 generation to 1998.
- Decided
- Nov 20, 2007
- Review
- 60 days
- Class
- Class II
- Product code
- JNL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K981559 (1998). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK981559 Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg AssayPharmacia & Upjohn Co. · 1998
- This deviceK072661 Immunocap Thyrlobulin ImmunocapPhadia US, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K981559 | Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg Assay | Pharmacia & Upjohn Co. | 1998 | — |
| 0 (this device) | K072661 | Immunocap Thyrlobulin Immunocap | Phadia US, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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 JNL? 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 JNL device
- #1 K250816 ADVIA Centaur Anti-Thyroglobulin II (aTgII)score 11.1 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K981559 | Unicap Thyroglobulin Igg Assay, Unicap Thyroid Peroxidase Igg AssaySummary page 1…ontrols NLH JZO II 866.5870 Substantial Equivalence to UniCAP TG Antibodies 510(k) number: k981559 UniCAP TPO Antibodies 510(k) number: k981930 CONFIDENTIAL AND PROPRIETARY_____… | 1998 |
| * | K981930 | Unicap Thyroid Peroxidase IggSummary page 1…quivalence to UniCAP TG Antibodies 510(k) number: k981559 UniCAP TPO Antibodies 510(k) number: k981930 CONFIDENTIAL AND PROPRIETARY_____ Page 39 ICONFIDENTIAL AND PROPRIETARY… | 1998 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All JNL devicesJNL Immunochemical, Thyroglobulin Autoantibody: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · JNL
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JNL
Too few JNL 510(k)s in any year since 2007 to give a median.
Recalls per year · JNL
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JNL
1in 2025
MAUDE reports naming product code JNL, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 1 | — | 1 | 1 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 8 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 1 | — | 1 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
ImmunoCAP Thyroglobulin is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. ImmunoCAP Thyroglobulin is intended to be used with the ImmunoCAP 1000 and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' disease, and is to be used in clinical…
Read the full statement (253 words)
ImmunoCAP Thyroglobulin is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroglobulin (TG) in human serum and plasma. ImmunoCAP Thyroglobulin is intended to be used with the ImmunoCAP 1000 and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis and Graves' disease, and is to be used in clinical laboratories, as well as physician's office laboratories.
ImmunoCAP Thyroid Peroxidase is a device for the in vitro quantitative measurement of IgG antibodies specific for Thyroid Peroxidase (TPO) in human serum and plasma. ImmunoCAP Thyroid Peroxidase is intended to be used with the ImmunoCAP 1000 and ImmunoCAP 250 instruments. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of certain thyroid diseases, such as autoimmune thyroiditis, Graves' disease and is to be used in clinical laboratories, as well as physician's office laboratories.
ImmunoCAP Thyroglobulin IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroglobulin antibodies in human serum. ImmunoCAP Thyroglobulin IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 1000 and ImmunoCAP 250.
ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls NLH are intended for laboratory use in monitoring the performance of in vitro quantitative measurement of specific IgG Thyroid Peroxidase antibodies in human serum. ImmunoCAP Thyroid Peroxidase IgG Antibodies Controls are intended to be used with the instrument ImmunoCAP 1000 and ImmunoCAP 250.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072661 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072661: Immunocap Thyrlobulin Immunocap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072661
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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