FDA.reportPublic FDA data

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

Primary DI
00811403010028
Brand
SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
Company
Diamond Diagnostics Inc.
Model
0-DD-SMARTLYTEPLUS
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.
Published
2023-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
CEMElectrode, Ion Specific, Potassium
CGZElectrode, Ion-Specific, Chloride
JFPElectrode, Ion Specific, Calcium
JGSElectrode, Ion Specific, Sodium
JIHFlame Photometry, Lithium
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CEMElectrode, Ion Specific, PotassiumClinical Chemistry2
CGZElectrode, Ion-Specific, ChlorideClinical Chemistry2
JFPElectrode, Ion Specific, CalciumClinical Chemistry2
JGSElectrode, Ion Specific, SodiumClinical Chemistry2
JIHFlame Photometry, LithiumClinical Toxicology2
JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200544000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200544000SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc.2020-10-01CEM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00811403010028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00811403010028008114030100288114030100280811403010028

GMDN Terms#

Term, Definition table
TermDefinition
Ion-selective analyser IVDAn 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
947514303
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811403011469Glucose Electrode MembraneBK-670597D2023-06-12
00811403011667Glucose ReagentBK-472500D2023-06-12
00811403011636Glucose ElectrodeBK-469499D2023-06-10
00811403011131Glucose Reagent BK-443355D2023-06-05
00811403011605Albumin ReagentBK-467858D2023-06-10
00811403015504Maintenance KitHM-XEA328ASD2023-06-13
00811403015511O-Ring KitHM-XEA486ORD2023-06-13
00811403018901Vaccuum Pump Rebuild KitCO-67030079D2023-06-13
00811403019045Compressor Rebuild KitSX-28144879D2023-06-13
00811403019052Compressor Rebuild KitSX-44368656D2023-06-13
00811403013289Wash PackCD-473497D2023-06-13
00811403010158Photometer LampOY-MU8550D2023-06-13
00811403010240Reference SolutionIL-09756904D2023-06-13
00811403013074Pump Tubing KitCD-105673D2023-06-13
00811403013173C1/C2 Cleaning SolutionCD-473389D2023-06-13
00811403010387Wash PackCD-473497D2023-06-13
00811403013296pH ElectrodeCD-476267D2023-06-13
00811403013302Calcium ElectrodeCD-476268D2023-06-13
00811403013319Potassium ElectrodeCD-476270D2023-06-13
00811403013326Reference ElectrodeCD-476273D2023-06-13

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