510(k) · Cleared
Recalled · Class II · 2019Access Total T3 Reagents on the Access Immunoassay Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · CDP Radioimmunoassay, Total Triiodothyronine
Cleared on Oct 31, 1997 after a 14-day review. The FDA summary names its predicate without a number. It has been recalled 3 times.
- Decided
- Oct 31, 1997
- Review
- 14 days
- Class
- Class II
- Product code
- CDP
- Recalls
- 3
- 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 |
|---|---|---|---|
| * | — | Ciba Corning ACS™ T3 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 |
|---|---|---|---|---|
| Apr 30, 2019 | Class II | Z-2239-2020 | Other | The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687… |
| May 9, 2017 | Class II | Z-2635-2017 | Device Design | The Access immunoassays are susceptible to biotin interference. |
| Oct 11, 2011 | Class III | Z-2227-2012 | Device Design | A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0. |
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 clinical importance of total serum T3 determination is in the diagnosis of thyroid disorders. Elevated concentrations of T3 can be found in Grave's disease, and most other classical causes of hyperthyroidism. Decreased concentrations occur in primary hypothyroid diseases such as Hashimoto’s thyroiditis and neonatal hypothyroidism or secondary hypothyroidism due to defects at the hypothalamo-hypophyseal level.
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/K973966 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973966: Access Total T3 Reagents on the Access Immunoassay Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973966
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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