# K883181: Synchron CX4/CX5 Clinical Chemistry Analyzer Reage

- Pathway: 510(k) (Traditional)
- Applicant: Beckman Instruments, Inc.
- Decided: Sep 19, 1988 after 54 days
- Product code: CKA (Nadh Oxidation/Nad Reduction, Alt/Sgpt)
- Device class: 1
- Regulation: 21 CFR 862.1030
- 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.
20 later devices descend from it; 3 cite it directly.
0 of 21 devices 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.

## Most influential descendants
- K965240: Synchron LX 20 Clinical Chemistry System, Synchron LX Albumin Reagent, Synchron LX Creatinine Picric Reagent, Synchron L (1997), 17 descendants of its own
- K042291: Unicel DXC 600 and 800 Synchron Systems (2004), 11 descendants of its own
- K183688: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 5 descendants of its own
- K183678: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own
- K191298: i-STAT CHEM8+ cartridge with the i-STAT 1 System (2020), 4 descendants of its own

## Recalls of this device
- Aug 10, 2010 · Not classified · Z-1619-2011: The recall was initiated because Cartridge Glucose (GLU) on UniCel DxC and Synchron LX instruments may give falsely high results for moderately hemolysed samples. The Impact: (1) Neonatal samples draw
- Aug 26, 2009 · Not classified · Z-1229-2012: A recall was initiated because Beckman has confirmed that the standardization of the Immuno Protein Calibrator Set has been re-established to IFCC Reference Preparation for Plasma Proteins, BCR-470 be

Source page: https://510kreport.com/device/K883181
Methodology: https://510kreport.com/methodology