(52 days)
Not Found
No
The summary describes a flow cytometry system with software for data acquisition and analysis, but there is no mention of AI or ML technologies being used for the immunophenotyping or analysis processes. The performance studies are based on standard statistical methods, not AI/ML model evaluation.
No
The device is an in vitro diagnostic (IVD) tool used for immunophenotyping, specifically for the identification and enumeration of lymphocyte subsets. It is intended for use in clinical laboratories to analyze samples and assist in diagnosis, not to provide therapy or treatment to a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states "For in vitro diagnostic use." and mentions "Immunophenotyping in clinical laboratories, using previously cleared in vitro diagnostic assays for flow cytometry." and "Identification and enumeration of lymphocyte subsets in human cells in suspension." all of which are diagnostic activities.
No
The device description explicitly states that the BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer workstation, indicating it includes significant hardware components in addition to software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "For in vitro diagnostic use." It also describes the intended use as "Immunophenotyping in clinical laboratories, using previously cleared in vitro diagnostic assays for flow cytometry" and "Identification and enumeration of lymphocyte subsets in human cells in suspension." These are all activities performed on samples taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details a system used to analyze human cells in suspension, which is a key characteristic of IVD devices.
- Intended User/Care Setting: The intended user is "clinical laboratories," which are the typical settings where IVD testing is performed.
The combination of these factors clearly indicates that the BD FACSCanto II system is intended for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
- Immunophenotyping in clinical laboratories, using previously cleared in vitro . diagnostic assays for flow cytometry.
- Identification and enumeration of lymphocyte subsets in human cells in . suspension.
- 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
Device Description
The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer workstation. The fluidics cart contains operational fluids, the flow cytometer acquires and analyzes the sample, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping of assays prepared using the lyse/no-wash method, and BD FACSDiva software for manual immunophenotyping of assays prepared using the lyse/wash method.
The BD FACSCanto II system can optionally be used with the BD FACS Loader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software, and with the BD FACS Sample Prep Assistant II for automatic sample preparation of assays utilizing the lyse/no-wash method.
The BD FACSCanto II system is a modification of the BD FACSCanto system, bearing the same intended use, indications for use, and operating principle as its predicate device. Modifications have been made to the fluidics, optics, and electronics subsystems. Changes were also made to the sample introduction system, the BD FACS Loader option, and to the two software applications. These changes have been made to enhance the system's usability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Immunophenotyping in 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)
Method Comparison: Based on Method Comparison and Bias Estimation Using Patient Samples, CLSI document EP9-A2. Results: The BD FACSCanto II system demonstrated comparable accuracy relative to the predicate when running the BD Multitest IMK kit and BD Multitest 6-color TBNK assays.
Precision: Based on Evaluation of Precision Performance of Clinical Chemistry Devices, CLSI document EP5-A2. Results: The BD FACSCanto II system demonstrated acceptable precision when running the BD Multitest IMK kit and BD Multitest 6-color TBNK assays.
Linearity: Based on Evaluation of the Linearity of Quantitative Measurement Approaches: A Statistical Approach, CLSI document EP6-A. Results: The BD FACSCanto II system demonstrated acceptable linearity when running the BD Multitest IMK kit and BD Multitest 6-color TBNK assays.
% Agreement: Based on User Protocol for Evaluation of Qualitative Test Performance, CLSI EP12- A. Results: The BD FACSCanto II system demonstrated acceptable % agreement when running the BD HLA-B27 assay.
Reproducibility: Pairs (positive & negative) of specimens were tested in duplicate by multiple operators, twice daily for multiple operating days across different instruments. Results: The BD FACSCanto II system demonstrated acceptable reproducibility when running the BD HLA-B27 assay.
Carryover: Based on recommendations contained in Class II Special Controls Guidance Document: Premarket Notifications for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA, December 4, 2001. Results: The BD FACSCanto II system demonstrated acceptable 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.
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.
Not Found
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
§ 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.”
0
510(k) Summary
SEP 1 4 2006
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 _ KO 62087
Submitter Information
| Submitter: | BD Biosciences
2350 Qume Drive
San Jose, CA 9513 |
| ------------ | -------------------------------------------------------- |
|---|
- Contact: Carter Navarro Regulatory Affairs Specialist Tel .: (408) 954-2469 Fax: (408) 954-2495 carter navarro@bd.com
Summary Date: July 20, 2006
Device Name / Classification
Name: BD FACSCanto II system Class II (21 CFR 864.5220) – Automated differential cell counter Classification:
Substantially Equivalent / Predicate Device
The BD FACSCanto II system is substantially equivalent to the BD FACSCanto system with BD FACSCanto clinical software and BD FACSDiva software (premarket notifications K041074 and K040725).
1
Device Description
The BD FACSCanto II system is comprised of a flow cytometer, a fluidics cart, and a computer workstation. The fluidics cart contains operational fluids, the flow cytometer acquires and analyzes the sample, and the computer displays and prints the analysis. The flow cytometer utilizes three subsystems: fluidics, optics, and electronics. The computer workstation runs two software packages: BD FACSCanto clinical software for automatic immunophenotyping of assays prepared using the lyse/no-wash method, and BD FACSDiva software for manual immunophenotyping of assays prepared using the lyse/wash method.
The BD FACSCanto II system can optionally be used with the BD FACS Loader for automatic sample introduction, a standalone barcode reader for data input into BD FACSCanto clinical software, and with the BD FACS Sample Prep Assistant II for automatic sample preparation of assays utilizing the lyse/no-wash method.
The BD FACSCanto II system is a modification of the BD FACSCanto system, bearing the same intended use, indications for use, and operating principle as its predicate device. Modifications have been made to the fluidics, optics, and electronics subsystems. Changes were also made to the sample introduction system, the BD FACS Loader option, and to the two software applications. These changes have been made to enhance the system's usability.
Intended Use
The BD FACSCanto II system is intended for use as an in vitro diagnostic device for the identification and enumeration of lymphocyte subsets in human cells in suspension.
2
Technological Characteristics
The following summary table describes the similarities and differences between the BD FACSCanto II system and the BD FACSCanto system.
| Characteristic | BD FACSCanto system
(predicate) | BD FACSCanto II system
(new family member) |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|
| Intended use | In vitro diagnostic device for
identification and enumeration of
lymphocyte subsets in human cells
in suspension using the lyse/wash
and lyse/no-wash sample
preparation methods for flow
cytometry. | Same. |
| Device classification and
product code | Automated Differential Cell
Counter
21 CFR 864.5220
Product Code: GKZ | Same. |
| Lasers | Red - 488-nm argon ion
Blue - 635-nm diode | Same. |
| Optics | Laser light delivered by fiber optics
and prisms.
Emitted light delivered by
collection and fiber optics. | Same. |
| Electronics | Multiple electronics boards
containing acquisition electronics
components. | One consolidated acquisition
electronics board. |
| Maximum parameter
detection | Eight
(FSC, SSC, and six fluorophores). | Same. |
| Software | BD FACSCanto clinical software
v.1.0 or higher and
BD FACSDiva software v.4.0 or
higher. | BD FACSCanto clinical software
v.2.1 or higher and
BD FACSDiva software v.5.0.1 or
higher. |
| Instrument setup and
quality control | Automated setup using BD
FACSCanto clinical software and
BD FACS 7-color setup beads. | Same. |
| Sample introduction | Manual, or automated with the
optional BD FACS Loader. | Same. |
| Sample preparation | Manual pipetting for the lyse/wash
or lyse/no-wash methods, or
automated with the BD FACS
Sample Prep Assistant II for the
lyse/no-wash method. | Same. |
| Characteristic | BD FACSCanto system
(predicate) | BD FACSCanto II system
(new family member) |
| Sample type | Whole blood. | Same. |
| Accessories | Optional standalone barcode reader. | Same. |
3
Performance Data
| Study | Study Design | Results |
|---|---|---|
| Method | ||
| Comparison | Based on Method Comparison and Bias | |
| Estimation Using Patient Samples, CLSI | ||
| document EP9-A2. | The BD FACSCanto II system | |
| demonstrated comparable accuracy | ||
| relative to the predicate when | ||
| running the BD Multitest IMK kit | ||
| and BD Multitest 6-color TBNK | ||
| assays. | ||
| Precision | Based on Evaluation of Precision | |
| Performance of Clinical Chemistry Devices, | ||
| CLSI document EP5-A2. | The BD FACSCanto II system | |
| demonstrated acceptable precision | ||
| when running the BD Multitest IMK | ||
| kit and BD Multitest 6-color TBNK | ||
| assays. | ||
| Linearity | Based on Evaluation of the Linearity of | |
| Quantitative Measurement Approaches: A | ||
| Statistical Approach, CLSI document | ||
| EP6-A. | The BD FACSCanto II system | |
| demonstrated acceptable linearity | ||
| when running the BD Multitest IMK | ||
| kit and BD Multitest 6-color TBNK | ||
| assays. | ||
| % Agreement | Based on User Protocol for Evaluation of | |
| Qualitative Test Performance, CLSI EP12- A. | The BD FACSCanto II system | |
| demonstrated acceptable % | ||
| agreement when running the BD | ||
| HLA-B27 assay. | ||
| Reproducibility | Pairs (positive & negative) of specimens were | |
| tested in duplicate by multiple operators, | ||
| twice daily for multiple operating days across | ||
| different instruments. | The BD FACSCanto II system | |
| demonstrated acceptable | ||
| reproducibility when running the BD | ||
| HLA-B27 assay. | ||
| Carryover | Based on recommendations contained in Class | |
| II Special Controls Guidance Document: | ||
| Premarket Notifications for Immature or | ||
| Abnormal Blood Cells; Final Guidance for | ||
| Industry and FDA, December 4, 2001. | The BD FACSCanto II system | |
| demonstrated acceptable carryover. |
:
4
Conclusions from Performance Data
:
. . . . .
The BD FACSCanto II system demonstrates substantial equivalence to the predicate device.
100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 -
.
:
:
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP I 4 2006
BD Biosciences Immunocytometry Systems 2350 Oume Dr. San Jose, CA 95131 ATTN: Carter Navarro
Re: K062087
Trade/Device Name: BD FACSCanto II flow cytometer Regulation Number: 21 CFR 864.5220 Regulation Name: Automated Differential Cell Counter Regulatory Class: II Product Code: GKZ Dated: July 20, 2006 Received: July 24, 2006
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
6
Page 2 –
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 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 (240) 276-3150, or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Robert L. Rockey
Robert L. Becker, Jr., MD, Phe Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number: K062087
(if known)
Device Name: BD FACSCanto II System
Indications for Use:
- Immunophenotyping in clinical laboratories, using previously cleared in vitro . diagnostic assays for flow cytometry.
- Identification and enumeration of lymphocyte subsets in human cells in . suspension.
- For in vitro diagnostic use. .
- For use with or without the BD FACS Sample Prep Assistant II. .
Prescription Use _ X (Part 21 CFR 801 Subpart D)
AND/OR
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) | |
|---|---|
| ------------------------------------------------------------------- | -- |
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
510(k) K062087
al 510(k) Device Modification Notification
BD Biosciences Special 510(k) Device Modification Notifica
BD FACSCanto II System
07/20/2006
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