← Product Code [JJE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE) · K963539

# SIGMA DIAGNOSTICS WASH CONCENTRATE (K963539)

_Sigma Diagnostics, Inc. · JJE · Dec 16, 1996 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE/K963539

## Device Facts

- **Applicant:** Sigma Diagnostics, Inc.
- **Product Code:** [JJE](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE.md)
- **Decision Date:** Dec 16, 1996
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 862.2160
- **Device Class:** Class 1
- **Review Panel:** Clinical Chemistry

## Indications for Use

The Wash Concentrate is diluted to prepare Wash Solution, a dilute solution of wetting agents and preservatives. It is formulated to serve as a reagent diluent and a wash solution for the SYNCHRON CX®3 and all of its chemistries. The diluent allows the use of concentrated reagents that exhibit improved open stability over more dilute reagents.

## Device Story

Wash concentrate diluted to create wash solution; contains wetting agents and preservatives. Used with SYNCHRON CX®3 analyzer; functions as reagent diluent and system wash. Enables use of concentrated reagents with improved open stability. Operated by laboratory personnel in clinical settings. Output is a prepared chemical solution for instrument maintenance and reagent preparation; facilitates accurate diagnostic testing by ensuring system cleanliness and reagent integrity.

## Clinical Evidence

Bench testing only.

## Technological Characteristics

Liquid concentrate formulation; contains wetting agents and preservatives. Designed for dilution prior to use in SYNCHRON CX®3 clinical chemistry analyzer.

## Regulatory Identification

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

## Predicate Devices

- Beckman Wash Concentrate Solution Kit (Part No. 443335)

## Submission Summary (Full Text)

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K963539
Dec. 16, 1996

510(K) NOTIFICATION

Sigma Diagnostics
545 South Ewing Avenue
St. Louis, MO 63103

CX®3 Wash Concentrate
Procedure Number W0129
August 31, 1996

# SUMMARY OF SAFETY AND EFFECTIVENESS

The Wash Concentrate is diluted to prepare Wash Solution, a dilute solution of wetting agents and preservatives. It is formulated to serve as a reagent diluent and a wash solution for the SYNCHRON CX®3 and all of its chemistries. The diluent allows the use of concentrated reagents that exhibit improved open stability over more dilute reagents.

The safety and effectiveness of Sigma Diagnostics Wash Concentrate, Procedure Number W0129, are demonstrated by its substantial equivalency to Beckman Wash Concentrate Solution Kit, Part No. 443335.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE/K963539](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJE/K963539)

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