510(k) · Cleared
ClearedImmulite Free T4 (2-Step)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CEC Radioimmunoassay, Free Thyroxine
Cleared on Jul 25, 1997 as substantially equivalent to K822882 (Diagnostic Products Corp., 1982) after a 71-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Jul 25, 1997
- Review
- 71 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K822882 (1982). No later device cites it as a predicate yet.
- Root · 1 generation backK822882 Coat-a-Count Free Thyroxine Kit/ComponenDiagnostic Products Corp. · 1982
- This deviceK971792 Immulite Free T4 (2-Step)Diagnostic Products Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K822882 | Coat-a-Count Free Thyroxine Kit/Componen | Diagnostic Products Corp. | 1982 | — |
| 0 (this device) | K971792 | Immulite Free T4 (2-Step) | Diagnostic Products Corp. | 1997 | — |
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 CEC? 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 CEC device
- #1 K240273 Access Free T4score 7.0 · 1 generation · no Class I recall
- #2 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 |
|---|---|---|---|
| * | K822882 | Coat-a-Count Free Thyroxine Kit/ComponenSummary page 3…ogous tests. Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597 DPC's Registration Number 1s 2017183 DPC's Coat-A-Count® Free T4 (K822882) IMMULITE® Free T4 (2-Step) is a solid-phase, Chemiluminescent enzyme immunoassay for use with the IMMULITE® Automated Immunoass… | 1982 |
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?
- Its one ancestor has no recall.
How does its category compare?
All CEC devicesCEC Radioimmunoassay, Free Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CEC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · CEC
238in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · CEC
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CEC
213in 2025
MAUDE reports naming product code CEC, 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 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 3 | 7 |
| 2011 | 0 | — | 0 | 15 |
| 2012 | 1 | — | 0 | 6 |
| 2013 | 2 | — | 1 | 6 |
| 2014 | 3 | 238 | 0 | 40 |
| 2015 | 1 | — | 0 | 166 |
| 2016 | 1 | — | 0 | 148 |
| 2017 | 1 | — | 0 | 196 |
| 2018 | 2 | — | 1 | 199 |
| 2019 | 0 | — | 0 | 167 |
| 2020 | 0 | — | 0 | 106 |
| 2021 | 0 | — | 0 | 96 |
| 2022 | 0 | — | 0 | 81 |
| 2023 | 1 | — | 0 | 99 |
| 2024 | 1 | — | 0 | 276 |
| 2025 | 0 | — | 0 | 213 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DPC's IMMULITE® Free T4 is intended for use with the IMMULITE® Automated Analyzer. It is a solid-phase, 2-step chemiluminescent enzyme immunoassay designed for the quantitative measurement of non-protein-bound thyroxine (free T4) levels in serum. It is intended strictly for in vitro use as an aid in the clinical assessment of thyroid status related to abnormality in thyroid function or simply a variation (physiological or pathological) in the carrier…
Read the full statement (128 words)
DPC's IMMULITE® Free T4 is intended for use with the IMMULITE® Automated Analyzer. It is a solid-phase, 2-step chemiluminescent enzyme immunoassay designed for the quantitative measurement of non-protein-bound thyroxine (free T4) levels in serum. It is intended strictly for in vitro use as an aid in the clinical assessment of thyroid status related to abnormality in thyroid function or simply a variation (physiological or pathological) in the carrier proteins, chief of which is thyroxine-binding globulin (TBG). This assay is useful in assessment of thyroid status due to TBG elevations typical of pregnancy, oral contraceptive use and estrogen therapy. Additionally, this test system is for use as an aid in detecting alterations in the TBG level which mask the effects of abnormal thyroid function in hypothyroid and hyperthyroid patients.
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/K971792 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971792: Immulite Free T4 (2-Step).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971792
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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