For flow cytometer set up and monitoring of instrument performance prior to performing reticulocyte ennumeration or immunophenotyping applications. Flow cytometry has been found useful in monitoring some forms of immune disease.

For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur).

An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping.

For adjusting instrument settings: aligning the signal from the blue and the optional red laser (FL4 Option), setting the photomultiplier tube (PMT) voltages, and monitoring instrument performance over time.

For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals.

For monitoring the sensitivity of the side scatter (SSC) and fluorescence (FLI, FL2, FL3, and FL4) detectors and verifying adequate separation of system noise from forward scatter (FSC) signals.

For in vitro diagnostic use.

Device Description

Becton Dickinson FACSComp software and the CaliBRITE 4 bead kir (FACSComp/CaliBRITE 4) are intended for use on the Becton Dickinson flow cytometers, FACSort™ or FACSCalibur™, equipped with the FL4 Option. FACSComp/CaliBRITE 4 are used to check laser alignment, optimally adjust instrument settings, monitor sensitivity, and to set the compensation of flow cytometers for spectral overlap of fluorescent dyes. FACSComp/CaliBRITE 4 are used to set up and verify the separation of system noise from forward and side scatter and to set fluorescence compensation on flow cytometers with four fluorescence (FL) channels FACSComp/CaliBRITE 4 is used for setting the photomultiplier tube (PMT) voltages, setting the fluorescence compensation, and checking instrument sensitivity on flow cytometers. This product is recommended for instrument set up prior to running Becton Dickinson software applications for flow cytometers. The CaliBRITE beads are provided as a separate vial of CaliBRITE APC beads and the four-vial CaliBRITE 3 kit, comprised of unstained, FITC-, PE- and PerCP-labeled beads.

AI/ML Overview

The provided text describes the Becton Dickinson Immunocytometry Systems (BDIS) CaliBRITE™ APC beads, CaliBRITE 4 kit, and FACSComp™ software. This 510(k) submission (K973483) specifically aims to demonstrate substantial equivalence to a predicate device, the CaliBRITE™ 3 kit and FACSComp™ software (K961623).

The summary indicates that the new device is essentially the predicate device plus an additional component, the CaliBRITE APC beads, designed to facilitate the setup of the FL4 Option on certain flow cytometers. Due to this nature, the "acceptance criteria" and "device performance" are framed around demonstrating equivalence to the predicate device and the stability and reproducibility of the new components/system.

Here’s a breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly tied to the performance of the predicate device and the stability/reproducibility of the new system. The document does not explicitly list numerical acceptance criteria with target values. Instead, it states that the performance was "equivalent to the predicate device" for reproducibility aspects and provides stability durations.

Acceptance Criterion (Implied)	Reported Device Performance
Stability (Storage of Beads)	8 months under conditions of use
Stability (Diluted CaliBRITE APC and unlabeled beads - Tube A)	8 hours after dilution
Stability (Diluted five-bead preparation - Tube B)	1 hour after dilution
Reproducibility (Between bead lots)	Equivalent to the predicate device
Reproducibility (Within instrument across two computer platforms)	Equivalent to the predicate device
Reproducibility (Within setup options: lyse and wash (L/W) and lyse no wash (LNW) across colors)	Equivalent to the predicate device
Reproducibility (Between manual and automated 4-color LNW setup options)	Equivalent to the predicate device
Reproducibility (Within instrument over 20 days)	Equivalent to the predicate device

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

Sample Size: The document does not explicitly state the sample size (number of runs, number of beads tested, etc.) for the reproducibility or stability studies. It only mentions "Several studies were performed."
Data Provenance: The testing was "at Becton Dickinson Immunocytometry Systems laboratories in San Jose, California." This indicates the data is retrospective (performed as part of device development/verification) and from a single country of origin (USA).

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

Not applicable. This type of device (flow cytometer calibration beads and software) does not typically involve human expert interpretation for establishing "ground truth" in the way, for example, an imaging diagnostic AI would. The "ground truth" here is the expected performance of a well-calibrated flow cytometer, based on physical and chemical properties of the beads and the instrument's known specifications.

4. Adjudication Method for the Test Set

Not applicable. As noted above, human adjudication is not relevant for this type of device and its performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study focuses on human reader performance with and without AI assistance, which is not relevant for a calibration product like the CaliBRITE system.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is a calibration system used to set up and monitor flow cytometers. The FACSComp software automates certain tasks (e.g., setting PMT voltages, fluorescence compensation), which could be considered an "algorithm only" component in its execution of these tasks. However, its overall function is to prepare the instrument for human operators to then run diagnostic tests. The performance data presented focuses on the consistency and stability of this automated setup. It isn't a standalone diagnostic algorithm that produces a medical output without human oversight of the instrument's readiness.

7. The Type of Ground Truth Used

The ground truth used for these studies is based on:

Instrument Specifications: The expected ideal readings for properly calibrated flow cytometers using the CaliBRITE beads.
Predicate Device Performance: The established performance characteristics of the CaliBRITE 3 kit and FACSComp software (K961623) served as the benchmark for "equivalence."
Physical/Chemical Properties: The known characteristics of the fluorescent beads themselves (e.g., their fluorescence intensity) are inherent ground truth for their intended use in calibration.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML model in the contemporary sense that requires a "training set" of data. It's a calibration system whose "logic" or algorithms are based on established flow cytometry principles, not on learned patterns from a large dataset.

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

Not applicable, as there is no "training set" in the context of this device.

Summary

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K973483

Attachment G

FEB 1 7 1998

510(k) Summary

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

Submitter:	Becton Dickinson Immunocytometry System2350 Qume DriveSan Jose, CA 95131-1807
Contact:	Cindy MorrowSr. Regulatory Specialist

Summary date: December 17, 1997

Name of Device and Classification (21 CFR 807.92(a)(2))

(408) 954-2694

Name:	CaliBRITE™ APC beads, CaliBRITE 4 kit (unlabeled, FITC-, PE-, PerCP- and APC labeled CaliBRITE beads), and FACSComp™ software
Classification:	Accessory to a Class II Device

Predicate Device (21 CFR 807.92(a)(3))

CaliBRITE™ 4 kit and FACSComp™ software is substantially equivalent to CaliBRITE™ 3 kit (unlabeled, FITC-, PE-, and PerCP-labeled CaliBRITE beads) and FACSCOMP™ software, K961623, cleared to market on June 7, 1996.

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

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

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Comparison to Predicate Device (21 CFR 807.92(a)(6))

FACSComp/CaliBRITE 4 is substantially equivalent to FACSComp software and the CaliBRITE 3 kit, (K961623). The product is composed of four vials of beads that are identical to that of the predicate, and the new CaliBRITE APC vial, containing polystyrene beads conjugated with APC that are used to set up the FL4 Option.

The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence as found in the Federal Food, Drug, and Cosmetic Act, as amended and as applied under 21 CFR 807, Subpart E under which a device can be marketed without pre-market approval or reclassification. A determination of substantial equivalency under this notification is not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.

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

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

Several studies were performed:

· Stability was measured
1-

Storage stability of beads was determined to be 8 months under the conditions of use.

Once diluted, the two-bead preparation of CaliBRITE APC and unlabeled beads (Tube A) is stable for 8 hours. The five-bead preparation (Tube B) is stable for 1 hour after dilution.

· Reproducibility was measured

Berween bead lots.

Within instrument across two computer platforms.

Within the set up options of lyse and wash (L/W) and lyse no wash (LNW) across colors.

Between manual and automated 4-color LNW setup options.

Within instrument over 20 days.

Reproducibility was found to be equivalent to the predicate device.

Performance Data-Conclusions (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.

Clint Morris

Cindy Morrow. Sr Regulatory Specialist

12/17/97

Date

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three heads facing to the right, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the figure. The figure is black, and the text is also black.

Food and Drug Administration Cindy Morrow 2098 Gaither Road Sr. Regulatory Specialist Rockville MD 20850 Becton Dickinson Immunocytometry Systems FEB 1 7 1998 2350 Oume Drive San Jose, California 95131-9475 K973483 Re: Trade Name: Becton Dickinson Immunocytometry Systems (BDIS) CaliBRITE™ APC (Allophycocyanin) beads, CaliBRITE 4 kit (unlabeled, FITC, PE, PerCP, and APC labeled CaliBRITE beads), and FACSComp™ software. Regulatory Class: II Product Code: GKZ December 17, 1997 Dated: Received: December 18, 1997

Dear Ms. Morrow:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.

This letter will allow you to begin marketing your device as described in your 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

. . . .

Sincerely yours,

Steven Putman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

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Page	1 of 1
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510(k) Number (if known):	K973483
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Device Name:

Indications For Use:

Attachment A-Indications for Use:

For the FACS® family of flow cytometers (FACScan, FACSort and FACSCalibur).

An accessory device for instrument setup prior to performing reticulocyte ennumeration and immunophenotyping.

For automatically setting the fluorescence compensation of the detectors to adjust for spectral overlap of fluorescent signals.

For monitoring the sensitivity of the side scatter (SSC) and fluorescence (FLI, FL2, FL3, and FL4) detectors and verifying adequate separation of system noise from forward scatter (FSC) signals.

For in vitro diagnostic use.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.”