# K970905: Synchron CX Systems Lipase (Lipa) Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Jun 4, 1997 after 84 days
- Product code: CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase)
- Device class: 1
- Regulation: 21 CFR 862.1465
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K883181 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952180: CX Lipase Reagent & Calibrator for Synchron CX Systems, Beckman Instruments, Inc. (1995) Summary page 1.
- K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L, Beckman Instruments, Inc. (1997) Summary page 1.

## Recalls of this device
- Oct 25, 2004 · Not classified · Z-0262-5: Beckman Coulter has confirmed that occasionally a cuvette may be skipped during the SYNCHRON Lipase Wash (LIWA) procedure. If this occurs, there is the potential for carryover into the SYNCHRON Lipase

## Indications for use
The SYNCHRON Systems Lipase (LIPA) Reagent, in conjunction with SYNCHRON® Systems Lipase Calibrator, is intended for use in the guantitative determination of pancreatic lipase activity in serum or plasma samples. This assay is designed for use with clinical chemistry analyzers from Beckman Instruments, such as the SYNCHRON CX® and LX™ Clinical Systems.

Source page: https://510kreport.com/device/K970905
Methodology: https://510kreport.com/methodology