510(k) · Cleared
ClearedAbbott Architect Total T4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Laboratories · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Cleared on Nov 25, 1998 after a 57-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Nov 25, 1998
- Review
- 57 days
- Class
- Class II
- Product code
- KLI
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK983440 Abbott Architect Total T4Abbott Laboratories · 1998
- Descendant · cites it directly · 0 of its ownK151566 Abbott ARCHITECT Total T4 CalibratorsAbbott Laboratories · 2015
Most influential descendants
Showing 1 of 1 · See all- K151566Abbott ARCHITECT Total T4 CalibratorsAbbott Laboratories · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983440 | Abbott Architect Total T4 | Abbott Laboratories | 1998 | — |
| +1 | K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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 KLI? 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 |
|---|---|---|---|
| * | — | AXSYM Total T4 assay 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 |
|---|---|---|---|
| K151566 | Abbott ARCHITECT Total T4 Calibrators | 2015 | 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, K151566 (Abbott Laboratories, 2015) has gone furthest, with 0 descendants of its own.
How does its category compare?
All KLI devicesKLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KLI
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · KLI
Too few KLI 510(k)s in any year since 2007 to give a median.
Recalls per year · KLI
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KLI
3in 2021
MAUDE reports naming product code KLI, 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 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 1 | 3 |
| 2011 | 1 | — | 1 | 7 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 3 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 2 | 3 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The ARCHITECT™ Total T4 (TT4) assay is a Chemiluminescent Microparticle Immunoassay (CMIA) for the quantitative determination of thyroxine (total T4) in human serum and plasma. The ARCHITECT Total 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/K983440 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983440: Abbott Architect Total T4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983440
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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