ABX PENTRA MICRO ALB CONTROL L/H

K133676 · HORIBA ABX SAS · JJY · Jul 11, 2014 · Clinical Chemistry

Device Facts

• Record ID: K133676
• Device Name: ABX PENTRA MICRO ALB CONTROL L/H
• Applicant: HORIBA ABX SAS
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 11, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

ABX Pentra Micro ALB Control L/H is a quality control used to monitor the performance of ABX Pentra Micro ALBUMIN CP determination by immunoturbidimetry.

Device Story

ABX Pentra Micro ALB Control L/H is a two-level (Low/High) liquid quality control material; composed of human urine, added chemicals, human-origin constituents, stabilizers, and preservatives. Used on ABX PENTRA 400 benchtop clinical chemistry analyzer; operated by laboratory personnel. Device provides known values and confidence intervals for monitoring immunoturbidimetric microalbumin assays. Healthcare providers compare analyzer results against provided control ranges to verify assay precision and accuracy; ensures reliability of patient test results. No modifications to the analyzer are required for use.

Clinical Evidence

Bench testing only. Real-time stability studies confirmed shelf life of 24 months at 2-8°C and open vial stability of 90 days at 2-8°C. Acceptance criteria met.

Technological Characteristics

Liquid solution; human urine matrix with stabilizers/preservatives. Two-level (Low/High) control. 10mL vial format. Used for immunoturbidimetric assay quality control. No electronic components or software algorithms; standalone control material.

Indications for Use

Indicated for use as a quality control material to monitor the performance of ABX Pentra Micro ALBUMIN CP immunoturbidimetric assays on the ABX PENTRA 400 clinical chemistry analyzer.

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) #: k133676

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.