LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY

K132227 · Bio-Rad Laboratories · JJY · Oct 25, 2013 · Clinical Chemistry

Device Facts

• Record ID: K132227
• Device Name: LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAY
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Oct 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Immunoassay Premium 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 Immunoassay Premium Control is a multi-analyte, human serum-based quality control material; contains human/animal-derived constituents, chemicals, therapeutic drugs, stabilizers, and preservatives. Used in clinical laboratories to monitor precision of immunoassay testing procedures. Provided in liquid form; stored frozen (-20°C to -70°C). Laboratory personnel use the control by running it alongside patient samples; comparing observed results against provided mean values and ±3SD ranges. Discrepancies in control results alert clinicians to potential issues with laboratory technique, instrumentation, or reagents, ensuring reliability of patient test results. Does not provide diagnostic information directly; serves as a quality assurance tool for laboratory workflows.

Clinical Evidence

Bench testing only. Stability studies (accelerated and real-time) were conducted to establish shelf life, thawed (opened/unopened), and frozen aliquot claims. Acceptance criteria defined as recovery results within ±10% of time-zero values. No clinical trials or human subject data were required or provided.

Technological Characteristics

Human serum-based control; liquid form. Contains human/animal-derived constituents, chemicals, therapeutic drugs, stabilizers, and preservatives. Storage: -20°C to -70°C. Analyte-specific stability profiles established via bench testing. No software, electronics, or energy sources involved.

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 laboratories. No specific patient population, age, or gender restrictions apply as it is a laboratory control material.

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)

{0}

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

510(k) #: k132227

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.