CD-CHEX + RBC

K960894 · Streck Laboratories, Inc. · GGL · May 24, 1996 · Hematology

Device Facts

• Record ID: K960894
• Device Name: CD-CHEX + RBC
• Applicant: Streck Laboratories, Inc.
• Product Code: GGL · Hematology
• Decision Date: May 24, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems

Device Story

CD-Chex PLUS is an in vitro diagnostic control consisting of stabilized human red blood cells and human white blood cells in glass vials. It serves as a reference for normal peripheral blood leukocytes during flow cytometry analysis. The device is used by laboratory personnel to verify the performance of flow cytometry systems, specifically monoclonal antibody binding and the red cell lysing step. By providing a known reference, it allows clinicians to ensure the accuracy of immunophenotyping procedures. The control is stored at 2-10°C and is not intended for human use.

Clinical Evidence

Bench testing only. Four studies conducted: Lot-to-lot reproducibility and comparison to whole blood; site-to-site reproducibility and comparison to predicate device; long-term stability; and open-vial stability. Results demonstrated consistent reproducibility, stability for the entire product dating, and substantial equivalence to the predicate device.

Technological Characteristics

Suspension of stabilized human red and white blood cells. Packaged in 2.5 mL or 4.0 mL glass vials with polypropylene screw-top caps. Designed for use on Becton Dickinson and Coulter flow cytometry systems. Storage requirements: 2°C to 10°C; do not freeze.

Indications for Use

Indicated for use as a quality control for flow cytometry systems to evaluate monoclonal antibody binding and red cell lysing performance in clinical laboratories.

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

• CD-Chex (K920997)

Submission Summary (Full Text)

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K960894

# 510(k) Summary of Safety and Effectiveness

**510(k) Submitter:**
Streck Laboratories, Inc.
14306 Industrial Road
Omaha, Nebraska 68144
**MAY 24 1996**

**Official Correspondent:**
Theodore Heise, Ph.D.
Quality Assurance/Regulatory Affairs Manager
[phone]

**Date Prepared:**
May 13, 1996

**Names of Device:**
Trade Name: CD-Chex PLUS (K960894)
Common Name: Immunophenotyping control
Classification Name: White cell control (§864.8625)

**Predicate Device:**
CD-Chex (K920997) manufactured by Streck Laboratories

**Description:**
CD-Chex PLUS is a suspension of stabilized human red blood cells and human white cells packaged in glass vials containing 2.5 or 4.0 mL volumes. Closures are polypropylene screw-top caps. The vials are packaged in polystyrene jars.

**Intended Use:**
CD-Chex PLUS is intended to be used as a control for evaluating monoclonal antibody binding by flow cytometry. CD-Chex PLUS control cells possess surface antigens detectable with monoclonal antibodies. When these cells are stained with fluorescent antibodies and analyzed by flow cytometry they provide a reference for normal peripheral blood leukocytes. CD-Chex PLUS is designed for use on Becton Dickinson and Coulter flow cytometry systems

**Comparison with Predicate Device:**
Like CD-Chex, CD-Chex PLUS is intended to enable the user to verify satisfactory performance of flow cytometry systems. Both devices contain control cells which possess surface antigens detectable with monoclonal antibodies. Unlike CD-Chex, CD-Chex PLUS contains stabilized human red cells. This allows the user to verify proper performance of the red cell lysing step which gives the user a true positive procedural control.

**Discussion of Tests and Test Results:**
Four studies of CD-Chex PLUS were conducted: I) Lot to Lot Reproducibility and Comparison to Whole Blood; II) Site to Site Reproducibility and Comparison to Predicate Device; III) Long Term Stability; and IV) Open Vial Stability. Study results showed CD-Chex PLUS to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating.

**Conclusions Drawn from Tests:**
CD-Chex PLUS is a safe and effective control for immunophenotyping when used as instructed in the product package insert.

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Jar Label

FRANÇAIS. Contrôle d'immunologie pour la détermination des Classes de Définition. Disponible en filtrajes normal. Contact des Lauréants Humanes, Unipement pour diagnosis de VITRO. Consommé entre 2°C et 10°C. NE PAS CONGELER. Se référer à la notice de la boîte. LE MATERIEL HUMANE, QUELLES ÉTÉ PRODUIT À ÉTÉ DÉRIVÉ. À ÉTÉ TROUVE NON-RÉACTIF POUR L'ANTIGÈNE DE SURFACE DE L'HEPARTITÉ B, POUR LE VIRUS DE L'HEPARTITÉ C-INOË ET L'ANTICORPS WH EN UTILISANT DES TECHNIQUES SPÉCIFIÉES PAR LA FDA.

DEUTSCH. Vontade zur immunologischen Übereinstimmung. Mit normalen Anteil entziffert. Enthält humane Leukämien. Zur 45 VITRO Diagnose ausschließlich Sie 2-10°C lagern. NICHT EINFRIEDEN. Packungsbeilage beachten. DAS HUMANE AUSGANGS MATERIAL. AUS DEN DESES PRODUKT HERDESTELLT WURDE. WURDE MIT VON DER FDA VORGESCHRENDNEN METHODEN. UNTERSUCHT. HINDUPTLICH. HEPATITIS B. DIEINFLÄCHENMITTGEN. HEPATITIS C-VIRUS (HCV) (HD HV) WURÖRPER WURDEN KEINE REACTIONEN-FESTGESTELLT.

ITALIANI. Controllo immunologico per la Definizione dei Clucchi. Disponibile a Espressione Normale Contiene Leucociti Umani, HR - Referente di Brevetto. Solo per uso diagnostico di VITRO Consomere a 2-10°C. NON CONGELARE. Consulente Figlietto Illustrativo. QUESTO PRODOTTO È STATO COSTITUITO CON MATERIALE DI ORIGINE UMANA. CHE NON È RISULTATO POSITIVO AL VIRUS DELL'EPATITÀ B, C-INOË È ALL'ANTICORPO HIV SECONDO LE METODICHE CONSIGLIATE DALLA FDA.

ALL HUMAN SOURCE MATERIAL USED IN THE MANUFACTURE OF THIS PRODUCT HAS BEEN TESTED AND FOUND TO BE NON-REACTIVE FOR HEPATITIS B, VIRUS (Hibsag), HEPATITIS C-VIRUS (HCV ANTIBODY), AND HUMAN IMMUNODEFICIENCY VIRUS (HIV-HHV) (ANTIBODES) USING TECHNIQUES LICENSED BY THE U.S. FOOD AND DRUG ADMINISTRATION. RECAUSE NO AROMA TEST METHOD CAN OFFER COMPLETE ASSURANCE THAT THESE RITINGUENS ARE ABSENT. THIS PRODUCT SHOULD BE HANDLED IN ACCORDANCE WITH GOOD LABORATORY PRACTICES USING APPROPRIATE PRECAUTIONS.


ESPANOL. Contral immunológico para la determinación del Clúster. Disponible para resuentes normales. Contiene leucocitos humanos. Unicameras para el diagnóstico de VITRO. Mantener entre 2-10°C. NO CONGELAR. Var especificaciones en el prospecto usuario. MATERIAL DE ORIGEN HUMANO. NO PRESENTA REACTIVIDAD CRUZADA CON EL ANTIGENO DEL VIRUS DE LA HEPATITIS B, DEL VIRUS DE LA HEPATITIS C-INOË Y HIV. ANALISIS REALIZADO SEGÚN LAS ESPECIFICACIONES TÉCNICAS DE LA FDA.

CATALOG + 1W CATALOGUE / AATALOGNUMMER / NR CATALOGU / CATALOGO/

CONTENTI / CONTENU / INAALT / CONTENUTO / CONTEN/OO

LOT # / NP LOT / CHARGENNUMMER / NR LOTTO / No. DE LOTE /

EXP / DAT / (EXXP / VERFAILLIGM/UM / DATA DI SCADENZA / FECHA DE CADUC /



4.0 mL Vial Label

2.5 mL Vial Label