SIGMA DIAGNOSTICS WASH CONCENTRATE
Device Facts
| Record ID | K963539 |
|---|---|
| Device Name | SIGMA DIAGNOSTICS WASH CONCENTRATE |
| Applicant | Sigma Diagnostics, Inc. |
| Product Code | JJE · Clinical Chemistry |
| Decision Date | Dec 16, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.2160 |
| Device Class | Class 1 |
Intended 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.
Indications for Use
Indicated for use as a reagent diluent and wash solution for the SYNCHRON CX®3 clinical chemistry analyzer system.
Regulatory Classification
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)
Related Devices
- K022027 — CALIBRATING MATERIAL, BUFFERS, STANDARD · Mission Diagnostics · Jul 22, 2002
- K981795 — CLEANING SOLUTION (1) MODEL NUMBER A943-795, SALT BRIDGE SOLUTION MODEL NUMBER A943-794, CALIBRATION SOLUTION, PH 7.4 MO · Thermo Bioanalysis Corp. · Jun 12, 1998
- K020894 — CALIBRATING MATERIAL, CAL-PAK, BUFFERS · Mission Diagnostics · Apr 29, 2002
- K020596 — CALIBRATING MATERIAL,CAL-PAK, CAL & SLOPE STANDARDS · Diamond Diagnostics, Inc. · Mar 23, 2002
- K013850 — STANDARD A, STANDARD B, STANDARD C, CAL, SLOPE · Diamond Diagnostics, Inc. · Dec 21, 2001
