The beads are for use on a BD FACSCanto™ flow cytometer equipped with BD FACSCanto software. The beads are used to adjust detector voltages, to set fluorescence compensation and to monitor daily instrument performance. For In Vitro Diagnostic Use.

Device Description

BD FACS 7-color setup beads are intended for use on the BD FACSCanto flow cytometer equipped with a 488-nm blue laser, a 633-nm red laser, and six fluorescence detectors. BD FACS 7-color setup beads are provided as a lyophilized pellet contained in 25 individually packaged test tubes along with a bottle of BD FACS setup bead diluent.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Storage Stability (Beads)	7 months at 2-8°C
Stability (Diluted Mixed-Bead Preparation)	1 hour at 20-25°C or 8 hours at 2-8°C
Reproducibility (Between three bead lots)	Equivalent to the predicate device

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a distinct "test set" sample size. The reproducibility study was conducted using "three bead lots," which serves as the sample size for evaluating lot-to-lot consistency. The data provenance is Becton Dickinson Immunocytometry Systems laboratories in San Jose, California, suggesting a prospective, in-house study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This document does not indicate the involvement of external experts to establish ground truth for a test set. The performance data seems to be based on internal laboratory testing and comparison to a predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as there is no mention of a ground truth established by experts or a need for adjudication in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This device is a set of quality control beads for a flow cytometer, not an AI-assisted diagnostic tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is a physical product (beads) for instrument setup and monitoring, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth for performance evaluation appears to be based on established laboratory testing methods for stability and reproducibility, with a comparison to the performance of a legally marketed predicate device (CaliBRITE™ beads).

8. The Sample Size for the Training Set:

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm that requires a training set.

Summary

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510(k) Summary

SEP 1 0 2004

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

The assigned 510(k) number is K040026.

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

Submitter:	BD Biosciences Immunocytometry Systems, a business unit ofBecton, Dickinson and Company2350 Qume DriveSan Jose, CA 95131-1807
Contact:	Cindy Morrow

Sr. Regulatory Specialist (408) 954-2694

Summary date: June 17, 2004

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

BD FACSTM 7-color setup beads Name: Classification: Class I (Quality Control beads)

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

BD FACSTM 7-color setup beads are substantially equivalent to CaliBRITE™ beads cleared in K000897 (05/05/2000), K973483 (02/17/1998), K961623 (06/07/1996), and K925274 (09/30/1994).

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

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

For in vitro diagnostic use on a BD FACSCanto flow cytometer with BD FACSCanto software. The beads are used to adjust fluorescent detector voltages, to set fluorescence compensation, and to monitor daily instrument performance.

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

BD FACS 7-color setup beads are lyophilized and are rehydrated with BD FACS setup bead diluent or BD FACS bead dilution buffer. The beads are substantially equivalent to liquid BD CaliBRITE beads for flow cytometry setup. The product is composed of 25 test tubes, each containing a lyophilized pellet of beads packaged in air-tight single-use pouches. A bottle of BD FACS setup bead diluent is provided for use in rehydration of the beads prior to their use for setting up a suitably equipped flow cvtometer.

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

Performance of this product was established by testing at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California.

Studies performed:

Stability .
- Storage stability of beads was determined to be 7 months at 2-8°C. Once diluted, the mixed-bead preparation is stable for 1 hour at 20-25°C or 8 hours at 2-8°C.
· Reproducibility

Between three bead lots Reproducibility was found to be equivalent to the predicate device.

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

The results of the design verification studies demonstrate that the device is as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three parallel lines that curve and converge at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

SEP 1 0 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Cindy Morrow Sr. Regulatory Affairs Specialist Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, CA 95131

K040026 Re: Trade/Device Name: BD FACS 7-Color Setup Beads Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 23, 2004 Received: August 24, 2004

Dear Ms. Morrow:

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 (301) 594-3084. 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/dsma/dsmamain.html.

Sincerely yours,

Robert L. Becker, Jr.

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

Enclosure

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Indications for Use Statement

510(k) Number: K040026

Device Name: BD FACS 7-Color Setup Beads

Indications for Use:

The beads are for use on a BD FACSCanto™ flow cytometer equipped with . BD FACSCanto software.
The beads are used to adjust detector voltages, to set fluorescence . compensation and to monitor daily instrument performance.

Clinical Significance:

.. For In Vitro Diagnostic Use.
Over-The-Counter Use Prescription Use __ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joaphine Bautista
Division Sign-Off

Divis ion Sibn-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K040026

Page _________________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 864.5220 Automated differential cell counter.

(a)
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.(b)
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.”