AUTION CHECK PLUS

K142262 · Quantimetrix Corp. · JJW · Apr 10, 2015 · Clinical Chemistry

Device Facts

• Record ID: K142262
• Device Name: AUTION CHECK PLUS
• Applicant: Quantimetrix Corp.
• Product Code: JJW · Clinical Chemistry
• Decision Date: Apr 10, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The AUTION™ CHECK Plus is a quality control material intended for in vitro diagnostic use only, for performing quality control procedures with Arkray urine test strips and analyzers.

Device Story

AUTION CHECK Plus is a two-level liquid quality control material derived from human urine with added stabilizers and preservatives. It serves as a control for Arkray urine test strips and analyzers. The device is used in clinical laboratory settings to verify the performance of urinalysis testing. Operators (laboratory technicians) dispense the control into a sample tube and process it through Arkray urinalysis analyzers. The device provides known values for analytes including glucose, protein, bilirubin, urobilinogen, pH, blood, ketone, nitrite, leukocytes, and specific gravity. By comparing analyzer results against established control ranges, healthcare providers ensure the accuracy and reliability of patient urinalysis testing, thereby supporting clinical decision-making and diagnostic confidence.

Clinical Evidence

Bench testing only. Accelerated and real-time stability studies were conducted to establish shelf-life and open-vial stability claims. Value assignment was confirmed via laboratory analysis using three operators and three Arkray urinalysis analyzers, with results required to fall within pre-defined specification ranges.

Technological Characteristics

Liquid control material derived from human urine; contains stabilizers and preservatives. Packaged in 25 mL plastic squeezable bottles with dropper tips. Requires refrigerated storage (2-8°C). Shelf life of 18 months; open-vial stability of 30 days at 2-8°C. No software or electronic components.

Indications for Use

Indicated for in vitro diagnostic quality control procedures using Arkray urine test strips and analyzers.

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) #: k142262

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.