510(k) · Cleared
Recalled · Class II · 2018Immulite Thyroglobulin Model Lkty
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · MSW System, Test, Thyroglobulin
Cleared on Mar 12, 1999 as substantially equivalent to K972190 (American Laboratory Products Co., Ltd., 1997) after a 240-day review. Its family tree reaches back 1 generation to 1997. It has been recalled once.
- Decided
- Mar 12, 1999
- Review
- 240 days
- Class
- Class II
- Product code
- MSW
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972190 (1997). No later device cites it as a predicate yet.
- Root · 1 generation backK972190 Thyroglobulin Assay SystemAmerican Laboratory Products Co., Ltd. · 1997
- This deviceK982466 Immulite Thyroglobulin Model LktyDiagnostic Products Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972190 | Thyroglobulin Assay System | American Laboratory Products Co., Ltd. | 1997 | — |
| 0 (this device) | K982466 | Immulite Thyroglobulin Model Lkty | Diagnostic Products Corp. | 1999 | — |
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 MSW? 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 MSW device
- #1 K220972 Access Thyroglobulinscore 12.0 · 1 generation · 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 |
|---|---|---|---|
| * | K972190 | Thyroglobulin Assay SystemSummary page 1…alifornia 90045-5597 Establishment Registration Number EURO/DPC: Not applicable DPC: 2017183 Substantially Equivalent Predicate Device: ORGenTec Thyroglobulin ELISA (K972190) Manufactured by ORGenTec, and distributed in the USA by ALPCO, Windham, NH Description of Device: IMMULITE Thyroglobulin is a c… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 2, 2018 | Class II | Z-1684-2018 | Error in labeling | Concentrations for the level of biotin that does not interfere is not currently listed in the instruction for use for the Dimension Vista CTNI, Dimension Vista MMB, Dimension Sirolimus, ADVIA Centaur FOL, ADVIA Centaur aHBcM and the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K972190.
How does its category compare?
All MSW devicesMSW System, Test, Thyroglobulin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MSW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MSW
Too few MSW 510(k)s in any year since 2007 to give a median.
Recalls per year · MSW
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MSW
3in 2025
MAUDE reports naming product code MSW, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 2 | 57 |
| 2023 | 2 | — | 1 | 4 |
| 2024 | 2 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
IMMULITE Thyroglobulin is a two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Analyzer and designed for the quantitative measurement of thyroglobulin in serum or heparinized plasma. It is intended strictly for in vitro diagnostic use as an aid in monitoring patients who have undergone thyroidectomy.
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/K982466 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982466: Immulite Thyroglobulin Model Lkty.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982466
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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