# K932955: Ciba Corning Acs Progesterone Immunoassay

- Pathway: 510(k) (Traditional)
- Applicant: Ciba Corning Diagnostics Corp.
- Decided: Aug 2, 1993 after 46 days
- Product code: JLS (Radioimmunoassay, Progesterone)
- Device class: 1
- Regulation: 21 CFR 862.1620
- Recalls of this device: 11 (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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- Jan 4, 2017 · Class II · Z-1421-2017: DHEA-S causes falsely elevated progesterone results.
- Jan 4, 2017 · Class II · Z-1420-2017: DHEA-S causes falsely elevated progesterone results.
- Jan 4, 2017 · Class II · Z-1418-2017: DHEA-S causes falsely elevated progesterone results.
- Jan 4, 2017 · Class II · Z-1419-2017: DHEA-S causes falsely elevated progesterone results.
- Feb 4, 2016 · Class II · Z-1079-2016: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
- Feb 4, 2016 · Class II · Z-1078-2016: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
- Feb 4, 2016 · Class II · Z-1077-2016: ADVIA Centaur Systems Calibrator E Lot 42 and 43 Bias with the Testosterone Assay
- Jan 27, 2015 · Class II · Z-1231-2015: ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
- Jan 27, 2015 · Class II · Z-1230-2015: ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
- Jan 27, 2015 · Class II · Z-1229-2015: ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)
- Sep 26, 2014 · Class II · Z-0164-2015: Positive bias for Calibrator E lot kits ending in 38 and 39 with the ADVIA Centaur Systems Cortisol and Progesterone assays compared to the respective master curves.

Source page: https://510kreport.com/device/K932955
Methodology: https://510kreport.com/methodology