LIQUID ASSAYED MULTIQUAL PREMIUM

K130162 · Bio-Rad Laboratories · JJY · Mar 1, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130162
• Device Name: LIQUID ASSAYED MULTIQUAL PREMIUM
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Mar 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquid Assayed Multiqual Premium is intended for use as an assaved quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

Liquid Assayed Multiqual Premium is a multi-analyte control serum derived from human serum, supplemented with purified biochemicals, chemicals, drugs, preservatives, and stabilizers. It is provided in liquid form for laboratory use. The device serves as a quality control material to monitor the precision of laboratory testing procedures for a wide range of analytes. Laboratory personnel use the product by comparing test results against the provided mean values and ±3SD ranges, which are derived from replicate analyses and the Unity™ Interlaboratory Program. The control helps laboratories identify variations in technique, instrumentation, or reagents, thereby ensuring the reliability of patient diagnostic testing. It is intended for professional use in clinical laboratories.

Clinical Evidence

Bench testing only. No clinical data. Stability studies (real-time and accelerated) were conducted to establish shelf-life (3 years at -20 to -70°C) and thawed/opened vial stability (14 days at 2-8°C for most analytes, with specific exceptions for Direct Bilirubin, Triglycerides, HDL, Cholinesterase, and Phosphorus).

Technological Characteristics

Human serum-based control containing biochemicals, drugs, and stabilizers. Liquid form. Storage: -20 to -70°C. Analyte-specific mean values and ±3SD ranges provided. No electronic components or software algorithms.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical laboratory settings.

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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# Decision Summary

Statement for the Record, k130162

This 510(k) was reviewed under OIR's Triage 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.