CONE-TROL LIQUID CHEMISTRY CONTROLS

K121759 · Cone Bioproducts · JJY · Jul 24, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121759
• Device Name: CONE-TROL LIQUID CHEMISTRY CONTROLS
• Applicant: Cone Bioproducts
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jul 24, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

CONE-TROL Liquid Chemistry Control is a human liquid control serum to monitor the precision of laboratory testing procedures for the analytes listed in the package insert.

Device Story

CONE-TROL Liquid Chemistry Control is a human serum-based control containing biochemical materials, chemicals, drugs, preservatives, and stabilizers. It serves as an assayed quality control material to monitor the precision of laboratory testing procedures. The device is used in clinical laboratory settings by laboratory technicians or clinicians. The control is value-assigned using the Abaxis Piccolo Express Analyzer (utilizing reagent discs with built-in calibration) and traditional clinical chemistry analyzers (Roche Cobas Mira Plus, Mindray BS-200). Healthcare providers use the control results to verify the accuracy and precision of their diagnostic testing systems. By ensuring the reliability of laboratory measurements, the device helps clinicians make informed diagnostic and treatment decisions, ultimately benefiting patients through more accurate clinical laboratory results.

Clinical Evidence

Bench testing only. Stability studies confirmed closed vial stability at 2-8°C for 33 days, open vial stability at 2-8°C for 15 days, and shelf-life stability at -20°C for 254 days. Value assignment was performed using Abaxis Piccolo Express, Roche Cobas Mira Plus, and Mindray BS-200 analyzers.

Technological Characteristics

Human serum matrix with added biochemicals, drugs, preservatives, and stabilizers. Liquid form. Stored at -20°C or colder. Value assignment via Abaxis Piccolo Express reagent discs and standard clinical chemistry analyzers (Roche Cobas Mira Plus, Mindray BS-200).

Indications for Use

Indicated for use as a human liquid control serum to monitor the precision of laboratory testing procedures for specific analytes in clinical chemistry settings. No specific patient population, age, or gender restrictions apply as this is an in vitro diagnostic control product.

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, k121759

This 510(k) was reviewed under OIVD’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.