510(k) · Cleared
ClearedNichols Chemiluminescence Thyroglobulin, Model 60-4240
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nichols Institute Diagnostics · MSW System, Test, Thyroglobulin
Cleared on May 9, 2000 after a 153-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- May 9, 2000
- Review
- 153 days
- Class
- Class II
- Product code
- MSW
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK994140 Nichols Chemiluminescence Thyroglobulin, Model 60-4240Nichols Institute Diagnostics · 2000
- Descendant · cites it directly · 0 of its ownK021057 Brahms Diagnostica Dynotest TG-PlusBrahms Diagnostica, LLC · 2002
Most influential descendants
Showing 1 of 1 · See all- K021057Brahms Diagnostica Dynotest TG-PlusBrahms Diagnostica, LLC · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994140 | Nichols Chemiluminescence Thyroglobulin, Model 60-4240 | Nichols Institute Diagnostics | 2000 | — |
| +1 | K021057 | Brahms Diagnostica Dynotest TG-Plus | Brahms Diagnostica, LLC | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 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 |
|---|---|---|---|
| * | — | Kronus OptiQuant Thyroglobulin kit 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 |
|---|---|---|---|
| K021057 | Brahms Diagnostica Dynotest TG-Plus | 2002 | 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, K021057 (Brahms Diagnostica, LLC, 2002) has gone furthest, with 0 descendants of its own.
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?
The Nichols Institute Diagnostics Chemiluminescence Thyroglobulin is a two-site immunometric assay for the quantitative measurement of thyroglobulin in human serum. The assay is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had prior thyroidectomy (using surgery with or without radioiodine). This assay is also indicated for monitoring thyroglobulin levels in combination with radioiodine whole…
Read the full statement (225 words)
The Nichols Institute Diagnostics Chemiluminescence Thyroglobulin is a two-site immunometric assay for the quantitative measurement of thyroglobulin in human serum. The assay is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had prior thyroidectomy (using surgery with or without radioiodine). This assay is also indicated for monitoring thyroglobulin levels in combination with radioiodine whole body scans after either rhTSH administration or thyroid hormone withdrawal for detecting presence of thyroid tissue in patients with well-differentiated thyroid cancer. The assay should only be used on patients who lack thyroglobulin autoantibodies.
The presence of autoantibodies against thyroglobulin (TgAb) can interfere with assays for thyroglobulin, hence, the TgAb status of the patient should be determined and reported. Thyroglobulin antibodies can be quantitated with the Nichols Chemiluminescence Thyroglobulin Autoantibodies kit (catalog 60-4185).
The concentration of thyroglobulin (Tg) in a given specimen determined with assays from different manufacturers can vary due to difference in assay methods, reagent specificity, and presence of thyroglobulin autoantibodies. The results reported by the laboratory to the physician must include the identity of the Tg assay used. Values obtained with different assay methods cannot be used interchangeably. If in the course of serially monitoring a patient, the assay method used for determining Tg levels is changed, additional sequential testing should be carried out to confirm baseline values,
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/K994140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K994140: Nichols Chemiluminescence Thyroglobulin, Model 60-4240.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K994140
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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