HBA1C CONTROL, LEVEL 1 AND LEVEL 2

K131999 · Randox Laboratories, Ltd. · JJX · Jul 26, 2013 · Clinical Chemistry

Device Facts

• Record ID: K131999
• Device Name: HBA1C CONTROL, LEVEL 1 AND LEVEL 2
• Applicant: Randox Laboratories, Ltd.
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jul 26, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The HbA1c Controls Level 1 and 2 are intended for in vitro diagnostic use as quality control material for use to verify the performance of laboratory testing procedures of HbA1c on clinical chemistry systems. This device is intended for prescription use only.

Device Story

HbA1c Controls Level 1 and 2 are lyophilized quality control materials derived from hemolyzed human blood; used in clinical laboratories to monitor accuracy and precision of HbA1c testing on clinical chemistry analyzers. The product is supplied in vials requiring reconstitution with distilled water. Laboratory personnel use the controls by running them through the same testing procedures as patient samples. The resulting values are compared against assigned target ranges to verify system performance. This process helps ensure the reliability of clinical HbA1c measurements, which are critical for diagnosing and managing diabetes.

Clinical Evidence

No clinical data. Bench testing only. Stability studies confirmed performance at 2-8°C. Value assignment performed via consensus mean of at least two replicates on clinical chemistry analyzers, with acceptance criteria of CV ≤ 10% and target range of +/- 20%.

Technological Characteristics

Lyophilized hemolyzed human blood matrix; requires reconstitution with distilled water. Analyte: HbA1c. Traceability: IFCC via master equation (IFCC = (NGSP - 2.15) x 10.929). Storage: 2-8°C. No electronic components or software.

Indications for Use

Indicated for use as quality control material to verify performance of laboratory HbA1c testing procedures on clinical chemistry systems. Prescription use only.

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, k131999

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.