510(k) · Cleared
Recalled · 2011Access (R) Thyroxine Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Cleared on Jun 15, 1993 after a 168-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 15, 1993
- Review
- 168 days
- Class
- Class II
- Product code
- KLI
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK926475 Access (R) Thyroxine AssayBio-Rad Laboratories, Inc. · 1993
- Descendant · cites it directly · 0 of its ownK023369 Access Total T4 AssayBeckman Coulter, Inc. · 2002 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K023369Access Total T4 AssayBeckman Coulter, Inc. · 2002 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K926475 | Access (R) Thyroxine Assay | Bio-Rad Laboratories, Inc. | 1993 | — |
| +1 | K023369 | Access Total T4 Assay | Beckman Coulter, Inc. | 2002 | 5 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|
| K023369 | Access Total T4 Assay | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 10, 2011 | Not classified | Z-1949-2011 | Other | The recall was initiated because the concentration of total T4 in samples from pregnant women is erroneously low (20%) when measured using the Access Total T4 assay. Erroneously low results which are actually high (outside of the normal… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K023369 (Beckman Coulter, Inc., 2002) 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 | — |
https://510kreport.com/device/K926475 · printed Nov 4, 2026
Cite this page
510(k) Report. “K926475: Access (R) Thyroxine Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K926475
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026