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510(k) Data Aggregation
K Number
K181201Device Name
Synermed ISE Reagents
Manufacturer
Date Cleared
2018-07-10
(64 days)
Regulation Number
862.1665Why did this record match?
Applicant Name (Manufacturer) :
Infrared Laboratory Systems, LLC (dba Synermed)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Synermed ISE Reagents are used for in-vitro diagnostic use to quantitate levels of Sodium, Potassium and Chloride in serum. This device is for use in clinical laboratories only. Sodium measurements are used in the diagnosis and treatment of aldosteronism, diabetes insipidus and other diseases involving electrolyte imbalance. Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
Device Description
The Synermed ISE reagents contain the following ingredients: Sodium Chloride, Potassium Chloride, Sodium Bicarbonate, Potassium Phosphate. The ISE buffer contains trlethanolamine preservatives 0.1M, phosphoric acid 0.3% and nonreactive preservatives. The ISE Mid-Standard contains sodium chloride 2.96mM, potassium chloride 0.12M, buffer and non-reactive preservatives. The ISE Reference contains 1M potassium chloride.
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K Number
K172416Device Name
Synermed Opiate Enzyme Immunoassay
Manufacturer
Date Cleared
2018-04-19
(252 days)
Product Code
Regulation Number
862.3650Why did this record match?
Applicant Name (Manufacturer) :
Infrared Laboratory Systems, LLC (dba Synermed)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Synermed Enzyme Immunoassay is intended for the qualitative and semi-quantitative determination of opiates in human urine at a cutoff value of 300 ng/mL when calibrated against morphine. The assay is designed for professional use with a number of automated clinical chemistry analyzers. This assay is for prescription use only. The semi-quantitative mode is for purposes of enabling laboratories to determine an appropriate dilution of the specimen for confirmatory method such as GCMS or permitting laboratories to establish quality control procedures.
The assay provides only a preliminary analytical result. A more specific alternative analytical chemistry method must be used in order to obtain a confirmed analytical result. Gas or Liquid Chromatography/Mass Spectrometry (GC/MS or LC/ MS) are the preferred confirmatory methods. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary test result is positive.
Device Description
The Synermed Opiate Enzyme Immunoassay is ready to use. The composition of the Synermed Opiate Enzyme Immunoassay Reagent is as follows:
Antibody/Substrate Reagent (R1): Contains mouse monoclonal anti-morphine antibody, opiate-6-phosphate (G6P), nicotinamide adenine dinucleotide (NAD), stabilizers, and sodium azide (0.09 %) as a preservative.
Enzyme-drug Conjugate Reagent (R2): Contains morphine-labeled opiate-6-phosphate dehydrogenase (G6PDH) in buffer with sodium azide (0.09 %) as a preservative.
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K Number
K153692Device Name
Synermed Glucose Reagent, Synermed IR-1200 Chemistry Analyzer
Manufacturer
Date Cleared
2016-06-24
(184 days)
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
INFRARED LABORATORY SYSTEMS, LLC (DBA SYNERMED)
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Synermed Glucose Reagent is for the in vitro quantitative measurement of glucose in serum on the Synermed IR-1200 Chemistry Analyzer. Glucose measurements are used in the diagnosis and treatment of carbolygrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and of pancreatic islet cell carcinoma.
The Synermed IR-1200 Chemistry Analyzer is intended for in vitro diagnostic use as a multiparameter chemistry instrument that quantitates the levels of constituents in serum. The analyzer is an automated, random eccess, computer controlled, clinical chemistry analyzer for clinical chemistry tests. The instrument provides in vitro quantitative measurements for glucose in serum. The device is intended for use only in clinical laboratories.
Device Description
**Synermed IR-1200 Glucose Reagent**
The Synermed Glucose is ready to use. The composition of the Synermed Glucose Oxidase Reagent is as follows: 280 umol/L N-sulfopropyl-N-ethyl-3, 5-dimethylaniline, 280 umol/L ampyrone, 1400 U/L peroxidase (horseradish) and 18,000 U/L glucose oxidase.
**Synermed IR-1200 Chemistry Analyzer**
The IR-1200 Chemistry Analyzer is a multiparameter chemistry instrument that quantitates the levels of analytes in serum using spectrophotometric measurement. The system uses Synermed liquid-stable reagent systems that have been previously cleared by FDA.
The IR-1200 Chemistry Analyzer is a discrete analyzer with STAT priority capabilities and an externalized computer. The instrument features a user-friendly software operating system, optical unit, precision pipetting and electronic system. Twelve wavelengths are included ranging from 340 nm to 800 nm. The instrument's capabilities include: sample pipetting, reagent pipetting, anti-interference, mixing, pre-heating, reaction monitoring, calculation, display and printing of results. After the measurement is complete, the system rinses and dries the cuvettes. The system automates the manual functions and, as a result, it enhances efficiency, diminishes errors, thus improving the accuracy and precision of test results.
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