CONE-TROL HEMOGLOBIN A1C CONTROL SET

K121534 · Cone Bioproducts · JJX · Jun 20, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121534
• Device Name: CONE-TROL HEMOGLOBIN A1C CONTROL SET
• Applicant: Cone Bioproducts
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jun 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

CONE-TROL Hemoglobin A1c Control Set is intended for use as quality control material to monitor the performance and precision of Hemoglobin A 1c determination methods.

Device Story

CONE-TROL Hemoglobin A1c Control Set is a liquid quality control material derived from human blood, supplemented with chemicals, preservatives, and stabilizers. It is designed for use by laboratory personnel to monitor the performance and precision of Hemoglobin A1c (HbA1c) determination methods, specifically immunoassays and HPLC systems. The control is provided in two levels: Level 1 (clinically normal range) and Level 2 (clinically abnormal range). Value assignment is performed by assaying the control in triplicate on the target instrument system, requiring a minimum of 6 data points per level. Healthcare providers use the recovery of these control values to verify the accuracy and precision of their HbA1c testing, ensuring reliable patient results for diabetes management. The device is stored at -20°C for long-term stability and 2-8°C for open-vial use.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including value assignment protocols and stability studies. Stability was validated through accelerated studies (using the Arrhenius Equation/Q-rule) and confirmed by real-time stability testing at -20°C (closed vial) and 2-8°C (open vial) over 210 days. Performance was verified by ensuring analyte recovery remained within ±10% of the initial value.

Technological Characteristics

Liquid control material composed of human blood, stabilizers, and preservatives. Compatible with immunoassay and HPLC HbA1c test methods. Storage requirements: -20°C (closed) and 2-8°C (open). No electronic or software components.

Indications for Use

Indicated for use as quality control material to monitor the performance and precision of Hemoglobin A1c determination methods in clinical laboratory 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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Decision Summary, k121534

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.

OIVD, 6/12/12, v1.2