510(k) · Cleared
Recalled · Class II · 2015Access Free T3 Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · CDP Radioimmunoassay, Total Triiodothyronine
Cleared on Mar 29, 1996 after a 23-day review. The FDA summary names its predicate without a number. It has been recalled once.
- Decided
- Mar 29, 1996
- Review
- 23 days
- Class
- Class II
- Product code
- CDP
- Recalls
- 1
- Predicates
- 0
The FDA summary names its predicate without a number.
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 CDP? 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 |
|---|---|---|---|
| * | — | Magic® 1-Free T3 Radioimmunoassay Named without a submission number |
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 |
|---|---|---|---|---|
| Aug 31, 2015 | Class II | Z-0110-2016 | Under Investigation by firm | Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CDP devicesCDP Radioimmunoassay, Total Triiodothyronine: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CDP
FDA has decided no CDP device since 2007.
Median 510(k) review, days · CDP
Too few CDP 510(k)s in any year since 2007 to give a median.
Recalls per year · CDP
3in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CDP
25in 2025
MAUDE reports naming product code CDP, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 0 | 8 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 2 | 10 |
| 2014 | 0 | — | 1 | 111 |
| 2015 | 0 | — | 1 | 158 |
| 2016 | 0 | — | 0 | 150 |
| 2017 | 0 | — | 1 | 151 |
| 2018 | 0 | — | 3 | 365 |
| 2019 | 0 | — | 0 | 343 |
| 2020 | 0 | — | 0 | 209 |
| 2021 | 0 | — | 0 | 120 |
| 2022 | 0 | — | 0 | 123 |
| 2023 | 0 | — | 0 | 131 |
| 2024 | 0 | — | 0 | 41 |
| 2025 | 0 | — | 0 | 25 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACCESS® Free T3 assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of free trilodothyronine levels in human serum using the ACCESS® Immunoassay System. The Access® Free T3 assay aids in the diagnosis of hyperthyroidism.
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/K960913 · printed Nov 4, 2026
Cite this page
510(k) Report. “K960913: Access Free T3 Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K960913
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026