SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

Basic Information

• Brand Name: SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
• Primary DI: 00811403010028
• Version / Model: 0-DD-SMARTLYTEPLUS
• Company Name: Diamond Diagnostics Inc.
• Labeler DUNS: 947514303
• Distribution Status: 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: 59e64393-97ea-4ed0-b9ac-deb21aeec548

Device Description

The SmartLyte® Plus Na+, K+, Cl-, Ca++, Li+ Electrolyte Analyzer is a 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. The analyzer self-calibrates using Diamond Diagnostics Fluid Pack every 4 hours throughout the day or on request. 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): Yes
• 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
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	862.2160	1
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	862.1600	2
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	862.1665	2
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	862.1170	2
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	862.1145	2
JIH	Flame Photometry, Lithium	Clinical Toxicology	862.3560	2

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	00811403010028	GS1

Premarket Submissions

Submission Number	Supplement Number
K200544	000