510(k) · Cleared
Recalled · 2009Free T3 Calibrators on the Access Immunoassay Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Coulter, Inc. · JIT Calibrator, Secondary
Cleared on Oct 5, 2004 as substantially equivalent to K003098 (Beckman Coulter, Inc., 2000) after a 7-day review. Its family tree reaches back 1 generation to 2000. It has been recalled once.
- Decided
- Oct 5, 2004
- Review
- 7 days
- Class
- Class II
- Product code
- JIT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003098 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK003098 Access Ultrasensitive HGH CalibratorsBeckman Coulter, Inc. · 2000
- This deviceK042651 Free T3 Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003098 | Access Ultrasensitive HGH Calibrators | Beckman Coulter, Inc. | 2000 | — |
| 0 (this device) | K042651 | Free T3 Calibrators on the Access Immunoassay Systems | Beckman Coulter, Inc. | 2004 | — |
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 JIT? 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 |
|---|---|---|---|
| * | K003098 | Access Ultrasensitive HGH CalibratorsSummary page 1…brators claim substantial equivalence to the Beckman Coulter Access Ultrasensitive hGH Calibrators currently in commercial distribution, FDA 510O(k) Number K003098. 5.0 Device Description The Access Free T3 Calibrators are designed for use with the Access Free T3 Reagent f… | 2000 |
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 |
|---|---|---|---|---|
| Dec 17, 2009 | Not classified | Z-2178-2011 | Nonconforming Material/Component | Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K003098.
How does its category compare?
All JIT devicesJIT Calibrator, Secondary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIT
7in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JIT
28in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JIT
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIT
7in 2025
MAUDE reports naming product code JIT, 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 | 5 | 78 | 1 | 0 |
| 2008 | 6 | 46 | 0 | 0 |
| 2009 | 2 | — | 2 | 0 |
| 2010 | 6 | 65 | 0 | 3 |
| 2011 | 7 | 48 | 3 | 2 |
| 2012 | 2 | — | 3 | 10 |
| 2013 | 5 | 140 | 0 | 43 |
| 2014 | 10 | 33 | 2 | 9 |
| 2015 | 4 | 30 | 1 | 6 |
| 2016 | 4 | 33 | 0 | 3 |
| 2017 | 7 | 28 | 0 | 7 |
| 2018 | 0 | — | 5 | 8 |
| 2019 | 0 | — | 0 | 215 |
| 2020 | 0 | — | 2 | 12 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 1 | 6 |
| 2024 | 0 | — | 0 | 17 |
| 2025 | 0 | — | 0 | 7 |
| 2026 | 0 | — | 1 | — |
What is it indicated for?
The Access Free T3 Calibrator set is a device intended for medical purposes for use in the Access Immunoassay Systems to establish points of reference that are used in the determination of values in the measurement of free T3 levels in human serum and plasma.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042651 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042651: Free T3 Calibrators on the Access Immunoassay Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042651
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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