LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK

K130761 · Bio-Rad Laboratories · JJY · Apr 12, 2013 · Clinical Chemistry

Device Facts

• Record ID: K130761
• Device Name: LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 12, 2013
• 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, assayed quality control serum derived from defibrinated human plasma with added serum proteins, preservatives, and stabilizers. It is used in clinical laboratories to monitor the precision of testing procedures for a wide range of immunology analytes (e.g., CRP, Ferritin, Immunoglobulins, Complement components). The device is provided in multiple levels to allow for multi-point quality control. Laboratory personnel use the provided mean values and ±3SD ranges as guides to assess the performance of their testing instrumentation and reagents. By monitoring these control values, clinicians can identify potential variations in laboratory technique or instrument performance, ensuring the reliability of patient test results. The device is intended for professional use.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were conducted to validate thawed opened/unopened stability and shelf-life claims. Acceptance criteria were met for 5 days thawed/opened, 10 days thawed/unopened, and 2 years shelf-life at -20 to -50°C.

Technological Characteristics

Matrix: Defibrinated human serum. Form: Liquid. Analytes: Multi-analyte (e.g., CRP, Ferritin, Immunoglobulins, Complement). Storage: -20°C to -50°C. Stability: 5 days thawed/opened at 2-8°C; 10 days thawed/unopened at 2-8°C. 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) k130761

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.