LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK

K140764 · Bio-Rad Laboratories · JJY · Apr 25, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140764
• Device Name: LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 25, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Immunology Control is intended for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Immunology Control is a liquid, multi-analyte quality control serum derived from defibrinated human plasma; supplemented with serum proteins, stabilizers, and preservatives. Used in clinical laboratories to monitor the precision of testing procedures for various immunology analytes. The control is provided in liquid form; stored at -20 to -70°C until expiration. Healthcare providers use the control by running it alongside patient samples; comparing results against provided mean values and ±3SD ranges to verify assay performance. It benefits patients by ensuring the accuracy and reliability of clinical laboratory test results, thereby supporting informed clinical decision-making.

Clinical Evidence

Bench testing only. Stability studies (real-time and accelerated) were conducted to establish shelf life (24 months at -20 to -70°C) and thawed/opened stability claims for various analytes.

Technological Characteristics

Base matrix: defibrinated human plasma. Form: liquid. Storage: -20 to -70°C. Analytes include various serum proteins, immunoglobulins, and markers (e.g., CRP, Ferritin, Rheumatoid Factor). No software or electronic components.

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

510(k) #: k140764

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.