510(k) · Cleared
Recalled · Class II · 2026Access Total T4 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Cleared on Dec 9, 2002 as substantially equivalent to K926475 (Bio-Rad Laboratories, Inc., 1993) after a 62-day review. Its family tree reaches back 1 generation to 1993. It has been recalled 5 times.
- Decided
- Dec 9, 2002
- Review
- 62 days
- Class
- Class II
- Product code
- KLI
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 1 generation to K926475 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK926475 Access (R) Thyroxine AssayBio-Rad Laboratories, Inc. · 1993 · Recalled
- This deviceK023369 Access Total T4 AssayBeckman Coulter, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K926475 | Access (R) Thyroxine Assay | Bio-Rad Laboratories, Inc. | 1993 | 1 |
| 0 (this device) | K023369 | Access Total T4 Assay | Beckman Coulter, Inc. | 2002 | — |
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 |
|---|---|---|---|
| * | K926475 | Access (R) Thyroxine AssaySummary page 1…ccess@Immunoassay Systems. Substantial Equivalence Comparison The Access Total T4 assay is substantially equivalent to the previously cleared Access Total T4 assay (K926475). Both assays utilize the same methodology, are the same product type, and are quantitative. The subject and predicate assays inc… | 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 |
|---|---|---|---|---|
| Mar 16, 2026 | Class II | Z-1922-2026 | Nonconforming Material/Component | Beckman Coulter has identified that Access Total T4 Calibrator lots (PN 33805) exhibit a negative bias on DxI 600/800 instruments, with slopes outside product specifications. A false low patient result could cause a patient to undergo… |
| Feb 8, 2024 | Class II | Z-1303-2024 | Vendor change control | Four lots of Access Total T4 reagent lots demonstrated imprecision outside of the 10% specification which may result in erroneous or delayed results. |
| Jul 27, 2011 | Class II | Z-0613-2013 | Nonconforming Material/Component | A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim. |
| 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… |
| Aug 26, 2010 | Not classified | Z-3027-2011 | Nonconforming Material/Component | The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
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 Access Total T4 assay provides in vitro quantitative measurement of total thyroxine (T4) levels in human serum or plasma. The Access Total T4 assay is indicated for use with patients where an evaluation of their thyroid status is desired.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023369 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023369: Access Total T4 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023369
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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