HEMOCUE HEMOTROL

K964052 · Direct Solutions · GGM · Nov 6, 1996 · Hematology

Device Facts

• Record ID: K964052
• Device Name: HEMOCUE HEMOTROL
• Applicant: Direct Solutions
• Product Code: GGM · Hematology
• Decision Date: Nov 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Device Story

HemoTrol is a quality control material used to verify performance of HemoCue hemoglobin analyzers. It serves as a surrogate for whole blood samples to monitor system precision and accuracy. Used in clinical settings by healthcare professionals; provides known assay values for comparison against analyzer output. Helps ensure reliability of hemoglobin measurements; supports quality assurance workflows in point-of-care or laboratory environments.

Clinical Evidence

Bench testing only. Precision study conducted comparing three levels of HemoTrol against predicate HemoCue Whole Blood Control using three HemoCue B-Hemoglobin analyzers in replicates of 10. Shelf-life validation performed over 0-876 days at 2-8°C and 25°C.

Technological Characteristics

Liquid control material; matrix and chemical composition equivalent to predicate whole blood control. Designed for compatibility with HemoCue B-Hemoglobin analyzers. Stability validated for refrigerated and room temperature storage.

Indications for Use

Indicated for use as a quality control material for HemoCue hemoglobin analyzers to monitor the precision and accuracy of the testing system.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

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

Submission Summary (Full Text)

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K964052
NOV - 6 1996

Re: HemoCue HemoTrol 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 HemoTrol, which have been prepared in accordance with the FDA labeling requirements of 21 CFR 809.10.

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

For the purposes of demonstrating substantial equivalency, HemoCue HemoTrol 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 included 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 enclosed which provides supporting data relative to the product shelf life, open vial stability (room temperature 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. Six shelf life validation time studies, at 2-8°C and/or 25°C, over periods ranging from 0 to 876 days, incorporating a variety of production lots.

2. A precision study of three (3) levels each of HemoCue HemoTrol as compared to HemoCue Whole Blood Control (manufactured by Streck Laboratories), measured on three (3) different HemoCue B-Hemoglobin analyzers, in replicates of 10.

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