LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK

K140916 · Bio-Rad Laboratories · JJY · May 6, 2014 · Clinical Chemistry

Device Facts

• Record ID: K140916
• Device Name: LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJY · Clinical Chemistry
• Decision Date: May 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Cardiac Troponins 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 Cardiac Troponins Control is a trilevel liquid control serum derived from human protein with added human/animal constituents, stabilizers, and preservatives. Used in clinical laboratories to monitor the precision of Troponin I and Troponin T testing procedures. The device provides assayed mean values and ±3SD ranges to assist laboratories in verifying test performance. It is stored frozen (-20 to -70 °C) and has a 25-day open-vial stability at 2-8 °C. The control helps healthcare providers ensure the accuracy and reliability of cardiac marker assays, which are critical for diagnosing and managing cardiac events. It is intended for professional use by laboratory technicians.

Clinical Evidence

Bench testing only. Stability studies (real-time and accelerated) were conducted to validate shelf-life (18 months at -20 to -70 °C), frozen aliquot stability (30 days at -20 to -70 °C), and thawed/opened stability (25 days at 2 to 8 °C). Acceptance criteria were met.

Technological Characteristics

Trilevel liquid control; human protein matrix; contains stabilizers and preservatives. Storage: -20 to -70 °C. No electronic components, software, or energy sources. Sterility/Safety: Human source material tested non-reactive for HBsAg, HCV, and HIV-1/HIV-2.

Indications for Use

Indicated for use as an assayed quality control serum to monitor the precision of laboratory testing procedures for Troponin I and Troponin T. Intended for professional laboratory use.

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) #: k140916

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.