510(k) · Cleared
ClearedAccess Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · CHP Radioimmunoassay, Estradiol
Cleared on Feb 25, 1997 after a 42-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 25, 1997
- Review
- 42 days
- Class
- Class I
- Product code
- CHP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970126 Access Estradiol Reagents on the Access Immunoassay Analyzer…Bio-Rad Laboratories, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK080166 Access Estradiol Calibrators on the Access Immunoassay Systems…Beckman Coulter, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K080166Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545Beckman Coulter, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970126 | Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545) | Bio-Rad Laboratories, Inc. | 1997 | — |
| +1 | K080166 | Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545 | Beckman Coulter, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
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 CHP? 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 |
|---|---|---|---|
| * | — | Abbott IMx® Estradiol Kit Named without a submission number |
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 |
|---|---|---|---|
| K080166 | Access Estradiol Calibrators on the Access Immunoassay Systems, Model 33545 | 2008 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K080166 (Beckman Coulter, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All CHP devicesCHP Radioimmunoassay, Estradiol: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CHP
FDA has decided no CHP device since 2007.
Median 510(k) review, days · CHP
Too few CHP 510(k)s in any year since 2007 to give a median.
Recalls per year · CHP
7in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CHP
84in 2025
MAUDE reports naming product code CHP, 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 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 9 |
| 2010 | 0 | — | 1 | 12 |
| 2011 | 0 | — | 0 | 10 |
| 2012 | 0 | — | 0 | 15 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 18 |
| 2016 | 0 | — | 1 | 29 |
| 2017 | 0 | — | 1 | 39 |
| 2018 | 0 | — | 1 | 38 |
| 2019 | 0 | — | 0 | 36 |
| 2020 | 0 | — | 0 | 135 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 7 | 61 |
| 2023 | 0 | — | 0 | 60 |
| 2024 | 0 | — | 0 | 65 |
| 2025 | 0 | — | 0 | 84 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The ACCESS® Estradiol assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of Estradiol levels in human serum using the ACCESS® Immunoassay System.
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/K970126 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970126: Access Estradiol Reagents on the Access Immunoassay Analyzer (33550,33540,33545).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970126
Report an extraction error
Are you the manufacturer?
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