LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

K123663 · Bio-Rad Laboratories · JJY · Dec 27, 2012 · Clinical Chemistry

Device Facts

• Record ID: K123663
• Device Name: LIQUIDCHEK CARDIAC MARKERS PLUS CONTROL LT; LEVEL 1C, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 27, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Cardiac Markers Plus Control LT is intended for use as a quality control serum to monitor the precision of laboratory testing procedures for the analytes listed in this package insert.

Device Story

Liquichek Cardiac Markers Plus Control LT is a liquid quality control serum derived from human serum with added human/animal constituents, chemicals, preservatives, and stabilizers. It is used in clinical laboratories to monitor the precision of testing procedures for cardiac markers, including Troponin I, CK Total, CK-MB, Digitoxin, CRP, Myoglobin, and NT-proBNP. The control is provided in liquid form. Laboratory personnel use the control to verify the performance of their testing systems by comparing results against established mean values and ±3SD ranges provided in the insert. This monitoring helps ensure the accuracy and reliability of patient test results, aiding clinicians in diagnostic decision-making for cardiac conditions.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) were conducted to establish shelf-life (32.5 months at -20 to -50 °C) and thawed stability (10 days at 2-8 °C for both opened and unopened vials).

Technological Characteristics

Liquid control serum; human serum base with added human/animal constituents, chemicals, preservatives, and stabilizers. Analytes: Troponin I, CK Total, CK-MB, Digitoxin, CRP, Myoglobin, NT-proBNP. Storage: -20 to -50 °C. No software or electronic components.

Indications for Use

Indicated for use as a quality control serum to monitor the precision of laboratory testing procedures for specific cardiac marker analytes in a clinical laboratory setting.

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, k123663

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