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 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.

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.

AI/ML Overview

Device Acceptance Criteria and Study Details:

This document describes the acceptance criteria and study findings for the BD FACSCanto system with BD FACSCanto clinical software, specifically when used with the BD FACS Sample Prep Assistant II (SPA II). The device is intended for the identification and enumeration of lymphocyte subsets in human cells.

1. Table of Acceptance Criteria and Reported Device Performance:

Study	Acceptance Criteria (Implied from Study Design)	Reported Device Performance
Accuracy	Based on Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline, NCCLS document EP9-A. (Implies the new device's results should be comparable to the predicate device within acceptable bias limits).	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. (Implies the new device should show acceptable repeatability and/or reproducibility).	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. (Implies that carryover of samples should be below a specified acceptable limit).	The BD FACSCanto system with the BD FACS Sample Prep Assistant II demonstrated acceptable system carryover.

Note: The provided document does not explicitly state numerical acceptance criteria or specific thresholds for "comparable accuracy," "acceptable system precision," or "acceptable system carryover." These are derived from the interpretation of the study design and the reported conclusions. The predicate device (BD FACSCanto system with manual pipetting) serves as the benchmark for comparison.

2. Sample Size and Data Provenance:

Test Set Sample Size: Not specified in the provided document. The "Accuracy" study mentions "Patient Samples" but does not provide a number.
Data Provenance: Not specified. It can be inferred that the studies were conducted by the manufacturer, BD Biosciences, but the country of origin of the data (e.g., patient samples) and whether it was retrospective or prospective are not mentioned.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

Not applicable. The document describes studies for accuracy, precision, and carryover of a sample preparation system, not for diagnostic interpretation by human experts. Therefore, no experts were used to establish ground truth in the context of diagnostic assessment. The "ground truth" for these studies would be derived from the reference methods outlined in the NCCLS guidelines for accuracy and precision, and specific carryover protocols.

4. Adjudication Method (Test Set):

Not applicable, as no expert adjudication was involved in these performance studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices where human interpretation is a primary component. The BD FACSCanto system is an automated cell counter, and the studies focus on its analytical performance (accuracy, precision, carryover) relative to a manually operated predicate device, not on improving human reader performance.

6. Standalone (Algorithm Only) Performance:

Yes, a form of standalone performance was assessed. The studies evaluate the performance of the BD FACSCanto system with the automated BD FACS Sample Prep Assistant II (SPA II) as a complete, integrated system. The SPA II itself is an automation component that replaces manual pipetting. The evaluation implicitly defines its "standalone" performance within the context of the overall system's ability to prepare and analyze samples. The comparison is between the automated preparation method and the manual preparation method using the same core BD FACSCanto system.

7. Type of Ground Truth Used:

The ground truth for the performance studies would be established using reference methods and guidelines defined by NCCLS (National Committee for Clinical Laboratory Standards) documents EP9-A (Accuracy) and EP5-A (Precision). For carryover, it would be based on Class II Special Controls Guidance Document for Automated Differential Cell Counters. These guidelines provide standardized methods for assessing the analytical performance characteristics of laboratory devices, where "ground truth" is determined by well-controlled experiments and established reference measurements (e.g., highly accurate standard solutions or a gold-standard manual method if applicable, for accuracy studies).

8. Sample Size for the Training Set:

Not applicable. The provided document concerns the performance evaluation of a device, not the development or training of an AI algorithm on a dataset. Therefore, there is no mention of a "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established:

Not applicable, as no training set for an AI algorithm is mentioned or relevant to the described device and studies.

Summary

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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.

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

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

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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 withBD FACSCanto clinical softwareusing manual pipetting(predicate)	BD FACSCanto system withBD FACSCanto clinical softwareusing theBD FACS Sample Prep Assistant II
Intended Use	An in vitro diagnostic device foridentification and enumeration oflymphocyte subsets in human cells insuspension using a lyse no-washsample preparation method for flowcytometry.	Same.
Sample Type	Whole blood	Same.
Device Classificationand Product Code	Automated Differential Cell Counter21 CFR 864.5220Product Code: GKZ	Complete SystemSame.SPA II as stand-alone:Pipetting and Diluting Station forClinical Use21 CFR 862.2750Product 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.

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

Study	Study Design	Results
Accuracy	Based on Method Comparison and BiasEstimation Using Patient Samples;Approved Guideline, NCCLS documentEP9-A.	The BD FACSCanto system with the BDFACS Sample Prep Assistant IIdemonstrated comparable accuracy relativeto the predicate.
Precision	Based on Evaluation of PrecisionPerformance of Clinical Chemistry Devices;Approved Guideline, NCCLS documentEP5-A.	The BD FACSCanto system with the BDFACS Sample Prep Assistant IIdemonstrated acceptable system precision
Carryover	Based on recommendations contained inClass II Special Controls GuidanceDocument: Premarket Notifications forAutomated Differential Cell Counters forImmature or Abnormal Blood Cells; FinalGuidance for Industry and FDA.December 4, 2001.	The BD FACSCanto system with the BDFACS Sample Prep Assistant IIdemonstrated 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.

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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.

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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

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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

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

510(%) -----------------------------------------------------------------------------------------------------------------------------------------------------------------------

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.