EUROTROL GAS-ISE METABOLITES

K121468 · Eurotrol B.V. · JJY · Jun 22, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121468
• Device Name: EUROTROL GAS-ISE METABOLITES
• Applicant: Eurotrol B.V.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Eurotrol GAS-ISE Metabolites is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. Eurotrol GAS-ISE Metabolites was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. Eurotrol GAS-ISE Metabolites is also developed to verify calibration, operating temperature and other performance characteristics. Eurotrol GAS-ISE Metabolites is for professional use only. epoc Calibration Verification Fluids is an assayed blood gas, electrolyte and metabolite material, to verify the precision and accuracy of the epoc® Blood Analysis System. epoc Calibration Verification Fluids was designed to test the following analytes: pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine and tCO2. epoc Calibration Verification Fluids is also developed to verify calibration, operating temperature and other performance characteristics, epoc Calibration Fluids is for professional use only.

Device Story

Assayed liquid control material; used to verify precision, accuracy, and calibration of epoc Blood Analysis System. Input: physiologically buffered aqueous matrix containing salts, electrolytes, glucose, and lactate; equilibrated with CO2, O2, and N2. Output: reference values for pH, blood gases, electrolytes, and metabolites. Used in clinical settings by professionals. Healthcare providers compare measured analyzer results against assigned lot-specific values to ensure system performance and reliability. Benefits patient by ensuring accuracy of diagnostic blood analysis.

Clinical Evidence

Bench testing only. No clinical data provided. Value assignment performed via multiple replicates on epoc system using BGEM cards; traceability established against NIST SRM reference materials.

Technological Characteristics

Liquid control material in 3 mL clear glass ampules. Matrix: salts in physiologically buffered aqueous solution. Traceable to NIST SRM 186, 1674b, 956b, 965c, 967a. Stability: 12 months at 2-8°C unopened; 30 seconds after opening. No software or electronic components.

Indications for Use

Indicated for professional use to verify precision, accuracy, calibration, and operating temperature of the epoc Blood Analysis System for analytes including pH, pO2, pCO2, Na+, K+, Ca++, Mg++, Cl-, Glucose, Lactate, Urea, Creatinine, and tCO2.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

{0}

# Decision Summary

Statement for the Record, k121468

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.