BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962

K062087 · Bd Biosciences · GKZ · Sep 14, 2006 · Hematology

Device Facts

• Record ID: K062087
• Device Name: BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
• Applicant: Bd Biosciences
• Product Code: GKZ · Hematology
• Decision Date: Sep 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Indications for Use

The BD FACSCanto II system is intended for use as an in vitro diagnostic device for the identification and enumeration of lymphocyte subsets in human cells in suspension.

Device Story

The BD FACSCanto II is a flow cytometer system comprising a fluidics cart, flow cytometer, and computer workstation. It processes whole blood samples to identify and enumerate lymphocyte subsets. The system utilizes fluidics, optics (lasers/prisms), and electronics to acquire and analyze samples. It supports manual or automated sample introduction (via optional BD FACS Loader) and preparation (via optional BD FACS Sample Prep Assistant II). The computer workstation runs BD FACSCanto clinical software for automated immunophenotyping (lyse/no-wash) and BD FACSDiva software for manual immunophenotyping (lyse/wash). The system is operated by laboratory personnel in a clinical setting. Output is displayed and printed for clinical review, aiding in the identification and enumeration of lymphocyte subsets to support clinical decision-making.

Clinical Evidence

Bench testing only; design control activities and risk analysis performed to validate modifications.

Technological Characteristics

Flow cytometry system; modifications to fluidics, optics, and electronic subsystems; includes BD FACS Loader sample introduction system; software-controlled operation; design conforms to 21 CFR 820.30.

Indications for Use

Indicated for immunophenotyping in clinical laboratories using cleared in vitro diagnostic flow cytometry assays; identification and enumeration of lymphocyte subsets in human cells in suspension. For in vitro diagnostic use. For use with or without the BD FACS Sample Prep Assistant II.

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

• BD FACSCanto system (K041074, K040725)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification
ODE Review Memorandum

To: THE FILE
RE: DOCUMENT NUMBER K062087

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials.
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This submission is for the modification of the BD FACSCanto System.
4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, methodology, and automation. The modifications have been made to the fluidics, optics and electronic systems. Changes were also made to the sample introduction system in the BD FACS Loader option and to the two software applications.

A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

5. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.