SmartLyte Electrolyte Analyzer

Basic Information

• Brand Name: SmartLyte Electrolyte Analyzer
• Primary DI: 00811403019892
• Version / Model: 0-DD-SMARTLYTE
• Company Name: Diamond Diagnostics Inc.
• Labeler DUNS: 947514303
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-06-05
• Public Version: 1
• Public Version Date: 2023-06-13
• Public Version Status: New
• Public Device Record Key: 319f766d-3d2e-4495-af46-19edbbb34dac
• Distribution End Date: 2023-06-05

Device Description

SmartLyte® Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer which tests serum, plasma, whole blood, pre-diluted urine samples, and QC materials. It is microprocessor-controlled analyzers which utilize ion-selective electrodes for the measurement of sodium, potassium, chloride, calcium and lithium in serum, plasma, whole blood, pre-diluted urine samples, and QC materials. Sodium, potassium, chloride and calcium are commonly measured for use in the diagnosis and management of patients with a broad range of renal, metabolic and cardiovascular disorders. Lithium is a drug used to treat mental illness.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	862.1170	2
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	862.1145	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
JIH	Flame Photometry, Lithium	Clinical Toxicology	862.3560	2
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1

GMDN Terms

Code	Name	Definition	Implantable	Status
56682	Ion-selective analyser IVD	An electrically-powered automated or semi-automated laboratory instrument intended to be used for the quantitative measurement of electrolytes and/or other ions in a clinical specimen using ion-specific membranes to selectively measure electrical potential against a reference electrode to determine the target ion concentration.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00811403019892	GS1