# K953084: Access Ultrasensitive Insulin Assay

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad Laboratories, Inc.
- Decided: Sep 25, 1995 after 84 days
- Product code: CFP (Radioimmunoassay, Immunoreactive Insulin)
- Device class: 1
- Regulation: 21 CFR 862.1405
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 21, 2023 · Class II · Z-0981-2024: 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 Ult
- Sep 19, 2007 · Not classified · Z-1160-2008: False negative results when used to test serum samples (as compared to plasma samples).

Source page: https://510kreport.com/device/K953084
Methodology: https://510kreport.com/methodology