510(k) · Cleared
Recalled · Class II · 2023Access Ultrasensitive Insulin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · CFP Radioimmunoassay, Immunoreactive Insulin
Cleared on Sep 25, 1995 after an 84-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 2 times.
- Decided
- Sep 25, 1995
- Review
- 84 days
- Class
- Class I
- Product code
- CFP
- Recalls
- 2
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in CFP? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
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 |
|---|---|---|---|---|
| Nov 21, 2023 | Class II | Z-0981-2024 | Software design | There is an issue with the Access Ultrasensitive Insulin assay protocol file (APF) for use with the DxI 9000 Access Immunoassay Analyzer (APF 182 test definition version 6.7 and below). The Access Ultrasensitive Insulin APF applies an… |
| Sep 19, 2007 | Not classified | Z-1160-2008 | Other | False negative results when used to test serum samples (as compared to plasma samples). |
No ancestor or descendant has a Class I recall.
How does its category compare?
All CFP devicesCFP Radioimmunoassay, Immunoreactive Insulin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · CFP
FDA has decided no CFP device since 2007.
Median 510(k) review, days · CFP
Too few CFP 510(k)s in any year since 2007 to give a median.
Recalls per year · CFP
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · CFP
17in 2025
MAUDE reports naming product code CFP, 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 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 2 | 8 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 3 |
| 2017 | 0 | — | 0 | 4 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 7 |
| 2023 | 0 | — | 1 | 10 |
| 2024 | 0 | — | 1 | 7 |
| 2025 | 0 | — | 0 | 17 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K953084 · printed Nov 4, 2026
Cite this page
510(k) Report. “K953084: Access Ultrasensitive Insulin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K953084
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026