510(k) · Cleared
Recalled · Class II · 2013Immulite Free T3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Products Corp. · CDP Radioimmunoassay, Total Triiodothyronine
Cleared on Jan 2, 1998 as substantially equivalent to K932747 (Ciba Corning Diagnostics Corp., 1993) after a 21-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 2 times.
- Decided
- Jan 2, 1998
- Review
- 21 days
- Class
- Class II
- Product code
- CDP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K932747 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK932747 Ciba Corning Acs Free T3 ImmunoassayCiba Corning Diagnostics Corp. · 1993
- This deviceK974634 Immulite Free T3Diagnostic Products Corp. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K932747 | Ciba Corning Acs Free T3 Immunoassay | Ciba Corning Diagnostics Corp. | 1993 | — |
| 0 (this device) | K974634 | Immulite Free T3 | Diagnostic Products Corp. | 1998 | — |
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 CDP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K932747 | Ciba Corning Acs Free T3 ImmunoassaySummary page 1…os Angeles, California 90045-5597 Establishment Registration Number: DPC's Registration Number is 2017183 Substantially Equivalent Chiron Diagnostics' ACS:180 Free T3 (K932747) Predicate Device: ) Description of Device: IMMULITE® Free T3 is a solid-phase, Chemiluminescent enzyme immunoassay for use with… | 1993 |
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 |
|---|---|---|---|---|
| Aug 27, 2013 | Class II | Z-0867-2014 | Nonconforming Material/Component | Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the… |
| Aug 27, 2013 | Class II | Z-0868-2014 | Nonconforming Material/Component | Siemens Healthcare Diagnostics confirmed customer complaints regarding an increase in the number of euthyroid patients (those with normal function of the thyroid) demonstrating values above the recommended normal range as published in the… |
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 CDP devicesCDP Radioimmunoassay, Total Triiodothyronine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDP
FDA has decided no CDP device since 2007.
Median 510(k) review, days · CDP
Too few CDP 510(k)s in any year since 2007 to give a median.
Recalls per year · CDP
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDP
25in 2025
MAUDE reports naming product code CDP, 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 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 2 | 10 |
| 2014 | 0 | — | 1 | 111 |
| 2015 | 0 | — | 1 | 158 |
| 2016 | 0 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 151 |
| 2018 | 0 | — | 3 | 365 |
| 2019 | 0 | — | 0 | 343 |
| 2020 | 0 | — | 0 | 209 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 131 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
DPC's IMMULITE® Free T3 is a chemiluminescent assay for use with the IMMULITE® Automated Immunoassay Analyzer and is designed for the quantitative measurement of Free T3 in serum. It is intended strictly for in vitro diagnostic use as an aid in clinical assessment of thyroid status.
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/K974634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974634: Immulite Free T3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974634
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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