# K897150: Lipase Color [Toyo] Serum Lipase Test Kit

- Pathway: 510(k) (Traditional)
- Applicant: Toyo Jozo Co., Ltd.
- Decided: Feb 26, 1990 after 62 days
- Product code: CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase)
- Device class: 1
- Regulation: 21 CFR 862.1465
- Recalls of this device: 4 (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
- Apr 14, 2008 · Not classified · Z-2148-2008: Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
- Apr 14, 2008 · Not classified · Z-2150-2008: Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
- Apr 14, 2008 · Not classified · Z-2149-2008: Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.
- Apr 14, 2008 · Not classified · Z-2151-2008: Calibration and Quality Control outside of established range resulting from an increase in initial OD readings with the reagent contained within the kits.

Source page: https://510kreport.com/device/K897150
Methodology: https://510kreport.com/methodology