510(k) · Cleared
ClearedAbbott 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 27, 2012 as substantially equivalent to K983417 (Abbott Laboratories, 1998) after a 26-day review. Its family tree reaches back 1 generation to 1998. 2 later devices descend from it.
- Decided
- Nov 27, 2012
- Review
- 26 days
- Class
- Class II
- Product code
- CEC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K983417 (1998). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK983417 Abbott Architect Free T4Abbott Laboratories · 1998 · Recalled
- This deviceK123379 Abbott Architect Free T4Abbott Laboratories · 2012
- Descendant · cites it directly · 0 of its ownK173122 Abbott Architect Free T4Abbott Laboratories · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK152422 FREND™ Free T4 Test SystemNanoentek USA, Inc. · 2016
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K983417 | Abbott Architect Free T4 | Abbott Laboratories | 1998 | 2 |
| 0 (this device) | K123379 | Abbott Architect Free T4 | Abbott Laboratories | 2012 | — |
| +1 | K173122 | Abbott Architect Free T4 | Abbott Laboratories | 2017 | 1 |
| +1 | K152422 | FREND™ Free T4 Test System | Nanoentek USA, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K983417 | Abbott Architect Free T4Summary page 1…e Classification: Class 11 Classification Panel: Clinical Chemistry Product Code: CEC/JIT/JJX Legally marketed device to which equivalency is claimed: k9834 17, Abbott ARCHITECT Free T4 (LN 7K65-01; 2-point calibration) Attachment B (Contin… | 1998 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 a recall.
- Of its descendants, K173122 (Abbott Laboratories, 2017) has gone furthest, with 0 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. 2012, this device’s year, is highlighted.
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. The ARCHITECT Free T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when…
Read the full statement (125 words)
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.
The ARCHITECT Free T4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
The ARCHITECT Free T4 Controls are for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of free thyroxine (Free T4) in human serum and plasma when using the ARCHITECT Free T4 Reagent Kit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123379 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123379: 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/K123379
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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