VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit

K153712 · Radiometer America, Inc. · JJY · Jan 28, 2016 · Clinical Chemistry

Device Facts

• Record ID: K153712
• Device Name: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
• Applicant: Radiometer America, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jan 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

For in vitro diagnostic use. Verification Kits VK-3, VK-4, VK-R5, VK-R7 and VK-Crea are assayed quality control systems for calibration verification for the parameters and the analyzers listed in the insert specifying the control ranges.

Device Story

Verification Kits (VK-3, VK-4, VK-R5, VK-R7, VK-Crea) are calibration verification systems consisting of repackaged, previously 510(k)-cleared quality control solutions. Kits contain aqueous solutions (buffers, salts, metabolites, preservatives, dyes, and gases) in ampoules. Used in clinical laboratory settings to verify calibration and reportable ranges of chemistry analyzers. Healthcare providers use the output to confirm analyzer performance and ensure accurate patient test results. Benefits include standardized quality assurance and maintenance of analytical accuracy.

Clinical Evidence

No clinical data. Bench testing only; substantial equivalence is supported by reference to previously cleared 510(k) submissions for the constituent quality control solutions, confirming that repackaging does not affect stability, traceability, or value assignment.

Technological Characteristics

Liquid aqueous solutions containing biological buffers, salts, metabolites, enzymes, preservatives, and dyes; some equilibrated with CO2 and O2. Storage: 2-8°C (VK-3, R5, R7, Crea) or 2-25°C (VK-4). Traceability to IUPAC pH scale, NIST SRM, IFCC, and SIGMA. Standalone, non-electronic, non-software device.

Indications for Use

Indicated for in vitro diagnostic use as assayed quality control systems for calibration verification of parameters on specified 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) #: k153712

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.