MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE

K050191 · Becton, Dickinson & CO · PER · Feb 22, 2005 · Clinical Chemistry

Device Facts

• Record ID: K050191
• Device Name: MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
• Applicant: Becton, Dickinson & CO
• Product Code: PER · Clinical Chemistry
• Decision Date: Feb 22, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.2750
• Device Class: Class 1

Indications for Use

The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry. This is the same intended use as previously cleared for the BD FACSCanto system with BD FACSCanto clinical software.

Device Story

BD FACSCanto system with BD FACS Sample Prep Assistant II (SPA II) automates sample preparation for flow cytometry. SPA II is a microprocessor-controlled pipetting/diluting system; pierces sample tube caps; aliquots whole blood and reagents; mixes samples per protocols; adds lysing solution; automates cleaning. System integrates fluidic, optic, robotic, and electronic components. Used in clinical laboratories by trained personnel. Output is prepared samples for acquisition and analysis by the flow cytometer. Automating sample preparation reduces manual pipetting errors, improves workflow efficiency, and ensures consistent sample processing for lymphocyte subset enumeration, aiding clinical diagnosis and monitoring.

Clinical Evidence

Bench testing only; verification and validation activities performed per design control requirements; results demonstrated predetermined acceptance criteria were met.

Technological Characteristics

Flow cytometry system with automated sample preparation. SPA II components: robotic pipetting module (X/Y/Z axes), fluid pumps, barcode reader, central controller. Sample prep: lyse/no-wash method. Connectivity: microprocessor-controlled. Software: BD FACSCanto clinical software.

Indications for Use

Indicated for immunophenotyping in clinical laboratories using previously cleared IVD assays for flow cytometry (lyse/no-wash method). Includes enumeration of lymphocyte subsets: CD3+CD8+, CD3+CD4+, CD3-CD16+ and/or CD56+, CD3-CD19+, and CD3+. For in vitro diagnostic use; prescription use only.

Regulatory Classification

Identification

A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K050191

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 addition of the BD FACS Sample Prep Assistant II for sample preparation.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, methodology, comparison to the manual method. The BD FACS Sample Prep Assistant II provides automated sample preparation, pipetting, and primary and secondary tube mixing.

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.

(Reviewer's Signature)

(Date)

Revised: 3/27/98