RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3

K140393 · Randox Laboratories Limited · JJY · Mar 25, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140393
• Device Name: RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3
• Applicant: Randox Laboratories Limited
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Randox Ammonia Ethanol Control Levels 1, 2 & 3 are intended for in vitro diagnostic use in the quality control of Ammonia and Alcohol Assays to monitor precision and to detect systematic analytical deviations on clinical chemistry systems. This device is for prescription use only

Device Story

Randox Ammonia Ethanol Controls (Levels 1, 2, 3) are liquid, ready-to-use quality control materials; manufactured from saturated benzoic acid base matrix with added chemicals. Used in clinical chemistry laboratories to monitor precision and detect systematic analytical deviations in ammonia and alcohol assays. Controls are processed on clinical chemistry analyzers (e.g., ADVIA 1650, RX Daytona) alongside patient samples. Healthcare providers compare analyzer recovery of control values against assigned target ranges to validate assay performance. Benefits include ensuring accuracy and reliability of clinical diagnostic testing for ammonia and alcohol levels.

Clinical Evidence

Bench testing only. Stability studies confirmed 30-day open-vial stability at 2-8°C and 18-month shelf life at -75 to -90°C, with deviations ≤5% compared to fresh material. Value assignment performed via nested testing against master lots on clinical chemistry analyzers, with precision (CV) ≤10% for Level 1 and ≤7.5% for Levels 2 and 3.

Technological Characteristics

Liquid control material; base matrix of saturated benzoic acid with added chemicals. Supplied in 2ml vials. Storage: 2-8°C (unopened). Analyte levels assigned via enzymatic (UV) methods on clinical chemistry analyzers. No electronic components or software.

Indications for Use

Indicated for in vitro diagnostic quality control of ammonia and alcohol assays on clinical chemistry systems to monitor precision and detect systematic analytical deviations. For prescription use only.

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)

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

510(k) #: k140393

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.