CBC-4K HEMATOLOGY CONTROL

K970331 · R&D Systems, Inc. · JPK · Apr 16, 1997 · Hematology

Device Facts

• Record ID: K970331
• Device Name: CBC-4K HEMATOLOGY CONTROL
• Applicant: R&D Systems, Inc.
• Product Code: JPK · Hematology
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CBC-4K™ is a tri-level hematology control designed to document and monitor values obtained from Cell-Dyn® hematology instruments.

Device Story

CBC-4K™ is an in vitro diagnostic reagent; composed of human erythrocytes, mammalian leukocytes, and platelets in plasma-like fluid with preservatives. Used in clinical laboratories to verify accuracy/precision of Cell-Dyn® hematology analyzers. Run in same manner as patient specimens. Provides three levels of measured constituents. Enables monitoring of instrument stability and performance; aids healthcare providers in ensuring reliable hematology test results for patient diagnosis and management.

Clinical Evidence

Bench testing only. Stability studies conducted to verify recovery of values within expected ranges. Shelf life established at 80 days from shipment; open-vial stability established at 12 days.

Technological Characteristics

In vitro diagnostic reagent; human erythrocytes, mammalian leukocytes, platelets in plasma-like fluid with preservatives. Tri-level formulation. Designed for use with Abbott Cell-Dyn® hematology systems.

Indications for Use

Indicated for use as an in vitro diagnostic hematology control to monitor the accuracy and precision of Abbott Cell-Dyn® hematology systems.

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

• CBC-3K™ (K904464)

Submission Summary (Full Text)

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R&D SYSTEMS
K970331
510(k) SUMMARY CBC-4K™ HEMATOLOGY CONTROL
APR 16 1997

Date of Summary: January 27, 1997
Company/Institution name: R&D Systems, Inc.
614 McKinley Place N.E.
Minneapolis, MN 55413-2647
Contact Person: Sue Gallo
Phone: [phone]
Fax: [phone]
Trade name: CBC-4K™ Hematology Control
Classification/Common Name: Hematology Quality Control Mixture (per 21 CFR 864.8625)
Classification Code/Device Class: 81JPK Hematology Control Mixtures for Quality Control/Class II

## Substantial equivalence:

CBC-4K™ Hematology Control is substantially equivalent to CBC-3K™, a hematology control currently being sold for in vitro diagnostic use. CBC-3K™ is a trademark of R&D Systems, Inc., 614 McKinley Place N. E., Minneapolis, MN 55413. The FDA document number for the predicate device, CBC-3K™, is K904464.

## Device description:

CBC-4K™ is an in vitro diagnostic reagent composed of human erythrocytes, mammalian leukocytes and platelets suspended in a plasma-like fluid with preservatives. It is composed of stable materials that provide a means of verifying accuracy and precision of Cell-Dyn® Hematology Systems. Cell-Dyn® is a trademark of Abbott Diagnostics, Abbott Park, Illinois. CBC-4K™ is available in three levels of measured constituents and is run in the same manner as patient specimens.

## Intended use:

CBC-4K™ is a tri-level hematology control designed to document and monitor values obtained from Cell-Dyn® hematology instruments.

## Comparison of CBC-4K™ to the predicate device:

CBC-4K™ has the same intended use as the predicate device. The composition of CBC-4K™ is the same as the predicate device except a nucleated red blood cell surrogate has been added. This parameter is measured by the Cell-Dyn® 4000 but not by other models of Cell-Dyn® hematology analyzers.

## Discussion of performance data:

The determination of substantial equivalence is based on an assessment of performance data. Results of studies met acceptance criteria for stability tested by recovery of values within the Expected Range through the life of the product. The shelf life for this product is established as 80 days from shipment and the open-vial stability is 12 days provided that the product is properly handled according to the package insert instructions.

## Conclusions:

CBC-4K™ is intended for use as a control to monitor the stability of values obtained from the Abbott Cell-Dyn® Hematology Systems. The stability data demonstrate that CBC-4K™ is a stable material suitable to use as a control. CBC-4K™ is substantially equivalent to CBC-3K™ currently sold for in vitro diagnostic use.

Submitted by:
Sue Gallo
Sue Gallo, B.S., M.T. (ASCP)
Quality Assurance Coordinator

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R&D Systems, Inc.
614 McKinley Place N.E.
Minneapolis, MN 55413
Phone: [phone]
FAX: [phone]
WATS: [phone]
WATS: [phone]
Customer Service
Technical Service & QC Program