# K952816: Lipase Flex Reagent Cartridge

- Pathway: 510(k) (Traditional)
- Applicant: Dupont Medical Products
- Decided: Jul 20, 1995 after 30 days
- Product code: CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase)
- Device class: 1
- Regulation: 21 CFR 862.1465
- Recalls of this device: 3 (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
- Sep 7, 2018 · Class II · Z-0466-2019: There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
- Sep 7, 2018 · Class II · Z-0465-2019: There is lot to lot variability for QC and patient results when using the identified reagent cartridge lots.
- Mar 10, 2010 · Not classified · Z-0588-2011: Open Well instability: After calibration, QC shifts high (out of range) after the Flex Well is hydrated. Shifts of up to 20% have been observed in both QC and patient samplesas soon as two hours post 

Source page: https://510kreport.com/device/K952816
Methodology: https://510kreport.com/methodology