K Number

Device Name

MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE

Manufacturer

BECTON DICKINSON & CO.

Date Cleared

2005-02-22

(26 days)

Product Code

PER GKZ JQW

Regulation Number

862.2750

Intended 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. Indications for Use: - Immunophenotyping in clinical laboratories, using previously cleared IVD I assays for flow cytometry that utilize the lyse no-wash sample preparation method. - Immunophenotyping of lymphocyte subsets including CD3*CD8*, CD3*CD4*, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*. - For in vitro diagnostic use. - For use with or without the BD FACS Sample Prep Assistant II.

Device Description

The BD FACSCanto system with BD FACSCanto clinical software is a flow cytometry system designed for analyzing samples prepared with the lyse / no-wash method. The BD FACS Sample Prep Assistant II is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA II combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis with a flow cytometer. The SPA II pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning protocols. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

Not Found

Reference Devices

K970616

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a flow cytometry system and an automated sample preparation accessory. It mentions microprocessor control and preprogrammed protocols but does not contain any language suggesting the use of AI or ML for data analysis, interpretation, or decision-making. The performance studies focus on standard analytical metrics like accuracy, precision, and carryover, not metrics typically associated with AI/ML performance (e.g., AUC, sensitivity/specificity of an algorithm).

Therapeutic

No
The device is an in vitro diagnostic device used for identification and enumeration of lymphocyte subsets, not for direct treatment or therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells".

SaMD (Software as a Medical Device)

The device description explicitly details hardware components like a robotic pipetting module, power supply, central controller unit, fluid pumps, and a barcode reader, indicating it is not software-only.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "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..."
Indications for Use: The indications clearly describe its use for "Immunophenotyping in clinical laboratories" and "For in vitro diagnostic use."
Device Description: The device is designed for analyzing human cells in suspension using a sample preparation method for flow cytometry, which is a common technique in in vitro diagnostics.
Performance Studies: The performance studies (Accuracy, Precision, Carryover) are based on guidelines for evaluating clinical laboratory devices (NCCLS documents), further supporting its IVD classification.
Intended User/Care Setting: The intended user is "Clinical laboratories," which is a typical setting for IVD devices.

The device is designed to be used in vitro (outside the body) to analyze biological samples (human cells) for diagnostic purposes (identification and enumeration of lymphocyte subsets).

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Also listed as:

Immunophenotyping in clinical laboratories, using previously cleared IVD I assays for flow cytometry that utilize the lyse no-wash sample preparation method.
Immunophenotyping of lymphocyte subsets including CD3CD8, CD3CD4, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*.
For in vitro diagnostic use.
For use with or without the BD FACS Sample Prep Assistant II.

Product codes (comma separated list FDA assigned to the subject device)

GKZ, JQW

Device Description

The SPA II pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning protocols. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Flow cytometry system

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinical laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study: Accuracy. Study Design: Based on Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, NCCLS document EP9-A. Results: The BD FACSCanto system with the BD FACS Sample Prep Assistant II demonstrated comparable accuracy relative to the predicate.
Study: Precision. Study Design: Based on Evaluation of Precision Performance of Clinical Chemistry Devices; Approved Guideline, NCCLS document EP5-A. Results: The BD FACSCanto system with the BD FACS Sample Prep Assistant II demonstrated acceptable system precision.
Study: Carryover. Study Design: Based on recommendations contained in 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. December 4, 2001. Results: The BD FACSCanto system with the BD FACS Sample Prep Assistant II demonstrated acceptable system carryover.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K970616

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 862.2750 Pipetting and diluting system for clinical use.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

Section 1.3 510(k) Summary

Section 1.3. 510(k) Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with the requirements of Safe Medical Devices Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is 1050191

Submitter Information (21 CFR 807.92(a)(1))

Submitter: BD Biosciences 2350 Qume Drive San Jose, CA 95131
Carter Navarro Contact: Regulatory Affairs Specialist (408) 954-2469 (408) 954-2495 (FAX) carter navarro@bd.com

Summary Date: January 26, 2005

Device Name / Classification (21 CFR 807.92(a)(2))

BD FACSCanto system with BD FACSCanto clinical software Name: Class II (21 CFR 864.5220) - Automated differential cell counter Classification:

Substantially Equivalent/Predicate Device (21 CFR 807.92(a)(3))

The BD FACSCanto system with BD FACSCanto clinical software, using the BD FACS Sample Prep Assistant II ("SPA II"), is substantially equivalent to the BD FACSCanto system with BD FACSCanto clinical software using manual pipetting. The SPA II and manual pipetting are used for the same sample type and result in similar performance characteristics.

Device Description (21 CFR 807.92(a)(4))

Intended Use (21 CFR 807.92(a)(5))

Technological Characteristics (21 CFR 807.92(a)(6))

The following summary table describes the similarities and differences between the BD FACSCanto system with BD FACSCanto clinical software using manual pipetting versus automated sample preparation using the BD FACS Sample Prep Assistant II.

| Characteristic | BD FACSCanto system with
BD FACSCanto clinical software
using manual pipetting
(predicate) | BD FACSCanto system with
BD FACSCanto clinical software
using the
BD FACS Sample Prep Assistant II |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | 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. | Same. |
| Sample Type | Whole blood | Same. |
| Device Classification
and Product Code | Automated Differential Cell Counter
21 CFR 864.5220
Product Code: GKZ | Complete System
Same.
SPA II as stand-alone:
Pipetting and Diluting Station for
Clinical Use
21 CFR 862.2750
Product Code: JQW |
| Preparation Method | Manual pipetting. | Automated. |

The SPA II is a modification of Tecan Systems' Mini Sample Processor (MSP) 9250, an OEM sister device of the MSP 9500 (cleared by FDA on April 21, 1997, under 510(k) number K970616). Substantial equivalence is not being claimed to the MSP 9500, since that device's product code (JQW) has since been designated as Class I, exempt from 510(k), and since the intended use of the SPA II brings it under the Class II designation of the incorporating BD FACSCanto system.

A brochure from Tecan Systems on these OEM sample preparation devices is provided in Section 2 for information only.

Performance Data (21 CFR 807.92(b)(1) and (2))

Study	Study Design	Results
Accuracy	Based on Method Comparison and Bias
Estimation Using Patient Samples;
Approved Guideline, NCCLS document
EP9-A.	The BD FACSCanto system with the BD
FACS Sample Prep Assistant II
demonstrated comparable accuracy relative
to the predicate.
Precision	Based on Evaluation of Precision
Performance of Clinical Chemistry Devices;
Approved Guideline, NCCLS document
EP5-A.	The BD FACSCanto system with the BD
FACS Sample Prep Assistant II
demonstrated acceptable system precision
Carryover	Based on recommendations contained in
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.
December 4, 2001.	The BD FACSCanto system with the BD
FACS Sample Prep Assistant II
demonstrated acceptable system carryover.

Conclusions from Performance Data (21 CFR 807.92(b)(3))

The BD FACSCanto system with BD FACSCanto clinical software using the BD FACS Sample Prep Assistant II demonstrates substantial equivalence to the predicate method.

Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of what appears to be an eagle.

FEB 2 2 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Carter Navarro Regulatory Affairs Specialist BD Biosciences 2350 Oume Drive San Jose, California 95131

K050191 Re:

Trade/Device Name: BD FACSCanto System with BD FACSCanto Clinical Software Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: January 26, 2005 Received: January 27, 2005

Dear Mr. Navarro:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

Page 2 –

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

lobatz Beckerh

Robert L. Becker, Jr., MD, Pa Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

Section 1.2 Indications for Use

Section 1.2. Indications for Use

510(k) Number (if known): _ Kazol9 |

Device Name: BD FACSCanto System with BD FACSCanto Clinical Software

Indications for Use:

Immunophenotyping in clinical laboratories, using previously cleared IVD I assays for flow cytometry that utilize the lyse no-wash sample preparation method.
트 Immunophenotyping of lymphocyte subsets including CD3CD8, CD3CD4, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*,
. For in vitro diagnostic use.
For use with or without the BD FACS Sample Prep Assistant II. 트

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE OF NEEDED

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Robert Z. Rocker
Division Sign-Off

Office of In Vitre Diagnostic Device Evaluation and Safety

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