510(k) · Cleared
Recalled · 2003Abbott Architect Free T4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · CEC Radioimmunoassay, Free Thyroxine
Cleared on Nov 20, 1998 after a 52-day review. The FDA summary names its predicate without a number. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- Nov 20, 1998
- Review
- 52 days
- Class
- Class II
- Product code
- CEC
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK983417 Abbott Architect Free T4Abbott Laboratories · 1998
- Descendant · cites it directly · 2 of its ownK123379 Abbott Architect Free T4Abbott Laboratories · 2012
- Descendant · 2 generations on · 0 of its ownK173122 Abbott Architect Free T4Abbott Laboratories · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK152422 FREND™ Free T4 Test SystemNanoentek USA, Inc. · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983417 | Abbott Architect Free T4 | Abbott Laboratories | 1998 | — |
| +1 | K123379 | Abbott Architect Free T4 | Abbott Laboratories | 2012 | — |
| +2 | K173122 | Abbott Architect Free T4 | Abbott Laboratories | 2017 | 1 |
| +2 | K152422 | FREND™ Free T4 Test System | Nanoentek USA, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 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 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 |
|---|---|---|---|
| * | — | AxSYM Free T₄ assay Named without a submission number |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123379 | Abbott Architect Free T4 | 2012 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 15, 2003 | Not classified | Z-0353-04 | Other | The calibrator lots may yield Free T4 values that are depressed. |
| May 30, 2003 | Not classified | Z-1132-03 | Other | The Free T4 Controls, may yield control values that are high and outside of the package insert ranges. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K123379 (Abbott Laboratories, 2012) has gone furthest, with 2 descendants of its own.
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?
The ARCHITECT™ Free T₄ (FT₄) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of free thyroxine (free T₄) in human serum and plasma. The ARCHITECT Free T₄ assay is to be used as an aid in the 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/K983417 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983417: Abbott Architect Free T4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K983417
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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