# K014034: Modification to Synchron LX Clinical Chemistry Systems (LX20 and LX20 Pro)

- Pathway: 510(k) (Special)
- Applicant: Beckman Coulter, Inc.
- Decided: Dec 18, 2001 after 11 days
- Product code: JFL (Ph Rate Measurement, Carbon-Dioxide)
- Device class: 2
- Regulation: 21 CFR 862.1160
- Recalls of this device: 4 (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.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- 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.
- K011213: Modification to Synchron LX 20 Clinical Chemistry System, Beckman Coulter, Inc. (2001) Summary page 1.

## Most influential descendants
- K040975: Genchem CO2 Acid Reagent (2004), 0 descendants of its own

## Recalls of this device
- Oct 10, 2003 · Not classified · Z-1098-04: Numeric results are erroneously accepted by the in-house information system without qualifying symbols "<" or ">". In addition, the in-house system may interpret the results incorrectly.
- Oct 7, 2003 · Not classified · Z-1116-04: 'Initial Rate High' parameter for User Defined Reagents does not perform as indicated in the Synchron LX Clinical Systems Operations Manual.
- Sep 18, 2003 · Not classified · Z-0096-04: Sample wheel may home to the wrong position.
- Dec 16, 2002 · Not classified · Z-0545-03: The disk that controls the home position of the sample wheel comes loose preventing a proper home sequence.

## Indications for use
SYNCHRON LX ISE Electrolyte Buffer Reagent, SYNCHRON LX ISE Electrolyte Reference Reagent, and CO2 Alkaline Buffer and Acid Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 3, are intended for quantitative determination of carbon dioxide (CO2) in serum or plasma on SYNCHRON LX Systems. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of calcium (CALC) in serum, plasma or urine on SYNCHRON LX Systems. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1 and 2, are intended for quantitative determination of chloride (CL) in serum, plasma, urine or cerebrospinal fluid (CSF) on SYNCHRON LX Systems. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of potassium (K) in serum, plasma or urine on the SYNCHRON LX System. SYNCHRON LX ISE Electrolyte Buffer Reagent and SYNCHRON LX ISE Electrolyte Reference Reagent, in conjunction with SYNCHRON LX AQUA CAL 1, 2 and 3, are intended for the quantitative determination of sodium (NA) in serum, plasma or urine on the SYNCHRON LX System.

Source page: https://510kreport.com/device/K014034
Methodology: https://510kreport.com/methodology