HEMOCUE HEMOLIN

K963908 · Direct Solutions · GGM · Oct 16, 1996 · Hematology

Device Facts

• Record ID: K963908
• Device Name: HEMOCUE HEMOLIN
• Applicant: Direct Solutions
• Product Code: GGM · Hematology
• Decision Date: Oct 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Device Story

HemoCue HemoLin is a control product used to verify the performance of HemoCue B-Hemoglobin analyzers. It serves as a quality control material to ensure the accuracy and precision of hemoglobin measurements. The device is used in clinical settings by healthcare professionals to validate analyzer function. It provides a known reference value for comparison against patient samples, allowing clinicians to confirm that the analyzer is operating within established specifications, thereby ensuring reliable diagnostic results for patient hemoglobin levels.

Clinical Evidence

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

Technological Characteristics

Liquid control matrix; chemical composition and packaging specifications equivalent to predicate HemoCue Whole Blood Control. Designed for compatibility with HemoCue B-Hemoglobin analyzers.

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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DIRECT SOLUTIONS

OCT 16 1996

K963908

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

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

For the purposes of demonstrating substantial equivalency, HemoCue HemoLin 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 attached 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 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. Six shelf life validation time studies, at 2-8°C and 25°C, over periods ranging from 0 to 876 days, incorporating a variety of production lots.
2. A precision study of five (5) levels of HemoCue HemoLin as compared to three (3) levels of 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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