EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM

K131595 · Eurotrol B.V. · JJY · Jul 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131595
• Device Name: EUROTROL GAS-ISE HCT QC AND EUROTROL GAS-ISE HCT LVM
• Applicant: Eurotrol B.V.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Eurotrol GAS-ISE Hct QC Eurotrol GAS-ISE Hct QC is an assayed aqueous quality control material for professional use in the verification of the precision and accuracy of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct QC should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring; pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit. Eurotrol GAS-ISE Hct LVM Eurotrol GAS-ISE Hct LVM is an assayed aqueous blood gas, electrolyte and metabolite control material for professional use suitable for calibration verification of the Abbott i-STAT® POCT analyzer. It is intended that Eurotrol GAS-ISE Hct LVM should be used in the periodic verification of the precision and accuracy of the Abbott i-STAT POCT analyzer when measuring; pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2 and Hematocrit.

Device Story

Eurotrol GAS-ISE Hct QC and LVM are aqueous, physiologically buffered quality control materials; used for periodic verification of precision and accuracy of Abbott i-STAT POCT analyzers. Controls are prepared via tonometry with predetermined levels of O2 and CO2 balanced with nitrogen and various salt concentrations to simulate clinically significant ranges of acid-base, electrolyte, respiratory, and metabolite parameters. QC provides 3 levels; LVM provides 5 levels. Used in clinical laboratories and point-of-care sites by healthcare professionals. Output is a comparison of measured values against assigned lot-specific ranges provided in value sheets. Helps ensure analytical performance of the i-STAT system; supports clinical decision-making by validating diagnostic accuracy.

Clinical Evidence

Bench testing only. Stability studies performed per CLSI EP25-A; precision evaluated per CLSI EP5-A2. Values assigned using multiple replicates on Abbott i-STAT 300 systems across multiple cartridge types (CG4+, CG8+, EC8+, CHEM8+, Crea). Traceability established to NIST SRM materials for pH, pCO2, pO2, Na+, K+, Ca++, Cl-, Glucose, Urea, and Creatinine.

Technological Characteristics

Aqueous, physiologically buffered salt solution. Tonometry-based gas equilibration. Packaged in clear glass ampules (2.5 mL). Storage 2-8°C. Shelf life 24 months. No biological materials. Standalone control material; requires Abbott i-STAT system for use.

Indications for Use

Indicated for professional in vitro diagnostic use as an assayed aqueous quality control material to verify precision and accuracy of the Abbott i-STAT POCT analyzer for pH, pO2, pCO2, Na+, K+, Ca++, Cl-, Glucose, Lactate, Urea, Creatinine, TCO2, and Hematocrit.

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}

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) #: k131595

This 510(k) was reviewed under OIR’s Triage-Quick Review 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.