R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)

K961610 · R&D Systems, Inc. · GKZ · Jul 1, 1996 · Hematology

Device Facts

• Record ID: K961610
• Device Name: R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
• Applicant: R&D Systems, Inc.
• Product Code: GKZ · Hematology
• Decision Date: Jul 1, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

R&D Systems’ Whole Blood Flow Control (WBFC) is a stabilized preparation of human peripheral leukocytes and erythrocytes to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance.

Device Story

Assay control mixture for flow cytometric leukocyte subset determination; composed of stabilized human leukocytes and erythrocytes. Used in clinical laboratories to verify immunophenotyping process, including antibody staining, RBC lysis, and instrument performance. Functions as reference material to ensure instrument precision and stability over product life. Provides quality control for flow cytometry workflows; enables verification of assay range and reproducibility compared to fresh whole blood. Stored at 2-8°C; 28-day closed vial/7-day open vial stability.

Clinical Evidence

Bench testing only. Evaluated stability and precision. Product remained within assay range over shelf life. Demonstrated low standard deviations and CVs. Precision compared favorably to freshly drawn whole blood.

Technological Characteristics

Stabilized preparation of human peripheral leukocytes and erythrocytes in a stabilizing medium. Form factor: liquid control in vials. Storage: 2-8°C. Shelf life: 28 days closed, 7 days open.

Indications for Use

Indicated for use as a control for flow cytometric immunophenotyping of leukocyte subsets in human whole blood samples; intended for laboratory use in monitoring instrument performance and assay procedures including antibody staining and RBC lysis.

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• CD Chex₂ (K920997)

Submission Summary (Full Text)

{0}

R&D SYSTEMS
JUL - 1 1996
K961610

# 510(k) Summary
## R&D Systems’ Whole Blood Flow Control

| Date of Summary: | April 25, 1996 |
| --- | --- |
| Company Name: | R&D Systems, Inc.
614 McKinley Place N.E.
Minneapolis, MN 55413 |
| Contact name: | Kenneth T. Edds, Ph.D.
612-379-2956, FAX [phone] |
| Classification name: | automated differential cell counter |
| Product name: | R&D Whole Blood Flow Control |
| CFR section: | 864.5220 |
| Device Class: | Class II |

Device to which substantial equivalence is claimed:
CD Chex₂ manufactured by Streck Laboratories, 14306 Industrial Rd. Omaha, NE 68144.
510(k) number: K920997

The product is an assay control mixture for flow cytometric determinations of leukocyte subsets present in whole blood samples. R&D Systems’ Whole Blood Flow Control is composed of human leukocytes and erythrocytes in a stabilizing medium.

Intended use: R&D Systems’ Whole Blood Flow Control (WBFC) is a stabilized preparation of human peripheral leukocytes and erythrocytes to be used as a control in the complete immunophenotyping process which includes: antibody staining, RBC lysis, instrument set-up and instrument performance.

R&D Systems’ Whole Blood Flow Control has an intended use that is similar to the predicate device but, in addition, includes the lysis of red blood cells in the control protocol. The technologies of the two devices are similar.

Nonclinical testing centered on the performance attributes of stability and precision. WBFC passed the acceptance criteria of remaining within the assay range over the life of the product. WBFC also demonstrated precision as indicated by the small standard deviations and low CVs obtained during the testing. WBFC was also compared, in terms of precision, to freshly drawn whole blood and found to exhibit similar reproducibility of performance. Expiration dating has been established as 28 days closed vial and 7 days open vial when stored at 2-8°C and handled according to instructions for use.

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