HEMOCUE GLUCOTROL

K964053 · Direct Solutions · JJX · Nov 1, 1996 · Clinical Chemistry

Device Facts

• Record ID: K964053
• Device Name: HEMOCUE GLUCOTROL
• Applicant: Direct Solutions
• Product Code: JJX · Clinical Chemistry
• Decision Date: Nov 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Device Story

HemoCue GlucoTrol is an assayed quality control material used to monitor the performance of HemoCue B-Glucose analyzers. It serves as a surrogate for whole blood samples to verify system accuracy and precision. Used in clinical settings by healthcare professionals; provides known glucose values to validate analyzer function; ensures reliable patient testing results.

Clinical Evidence

Bench testing only. Studies included open/closed vial glucose stability, day-to-day precision, and comparative precision testing of five levels of GlucoTrol versus three levels of predicate control across five HemoCue B-Glucose analyzers (replicates of six).

Technological Characteristics

Assayed liquid control material; matrix and chemical composition matched to predicate whole blood control; compatible with HemoCue B-Glucose analyzer systems.

Indications for Use

Indicated for use as an assayed quality control material for monitoring the performance of the HemoCue B-Glucose analyzer system.

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.

Predicate Devices

• HemoCue Whole Blood Control (manufactured by Streck Laboratories, Inc.)

Submission Summary (Full Text)

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DIRECT SOLUTIONS
K964053
NOV - 1 1996

Re: HemoCue GlucoTrol 510(k) Notification

## SMDA Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

## Representative Labels, Labeling and Advertisements

Included in this submission are samples or copies of the vial labels, box labeling, product description/instructions for use, and assay values for GlucoTrol, which have been prepared in accordance with the FDA labeling requirements of 21 CFR 809.10.

## Substantial equivalence of GlucoTrol control to devices already on the market

For the purposes of demonstrating substantial equivalency, HemoCue GlucoTrol control is compared to the HemoCue Whole Blood Control, manufactured for HemoCue by Streck Laboratories, Inc., 14306 Industrial Road, Omaha, Nebraska, 68144. Product descriptions, intended use and assay values for this product are provided for comparison.

These two products are similar in matrix, chemical composition, technological characteristics, intended use, and packaging specifications.

## Information and Data Supportive of Substantial Equivalency Claim

In addition to the product descriptions and intended use insert sheets referenced above, further evidence is provided which offers supporting data relative to the product shelf life, open vial stability (room temp. and 2-8°C), compatibility and non-interference with the intended analyzer, and comparable precision and accuracy as compared to the Streck Laboratories manufactured product. Test data include:

1. An open vial and closed vial glucose stability study.
2. A day-to-day precision study.
3. A precision study of five (5) levels of HemoCue GlucoTrol as compared to three (3) levels of HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on five different HemoCue B-Glucose analyzers, in replicates of six (6).

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