LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK

K123798 · Bio-Rad Laboratories · JJX · Jan 9, 2013 · Clinical Chemistry

Device Facts

• Record ID: K123798
• Device Name: LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK
• Applicant: Bio-Rad Laboratories
• Product Code: JJX · Clinical Chemistry
• Decision Date: Jan 9, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

Liquichek Diabetes Control is intended for use as an assayed quality control material to monitor the precision of laboratory testing procedures for the analyte listed in the package insert.

Device Story

Liquichek Diabetes Control is a liquid, human whole blood-based quality control material containing preservatives and stabilizers. Used in clinical laboratory settings by laboratory personnel to monitor the precision of testing procedures for Hemoglobin A1C. The control is provided with assigned mean values and ±3SD ranges. Laboratory staff compare their test results against these assigned values to verify the performance and stability of their analytical methods and reagents over time. The device helps ensure the accuracy and reliability of patient diabetes testing results.

Clinical Evidence

Bench testing only. Stability studies were conducted to establish shelf life (3 years at -10°C to -50°C), thawed unopened stability (180 days at 2°C to 8°C), and thawed open vial stability (14 days at 2°C to 8°C).

Technological Characteristics

Human whole blood matrix with preservatives and stabilizers. Liquid form. Shelf life: 3 years at -10°C to -50°C. Thawed stability: 14 days open/180 days unopened at 2°C to 8°C. Analyte: Hemoglobin A1C.

Indications for Use

Indicated for use as an assayed quality control material to monitor the precision of laboratory testing procedures for Hemoglobin A1C. No specific patient population or contraindications described as it is a laboratory 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

Statement for the Record, k123798

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.