(172 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional flow cytometry components and manual analysis software.
No
The device is described as an "In Vitro Diagnostic device for identification and enumeration of lymphocyte subsets," indicating it is used for diagnosis, not treatment.
Yes
This device is explicitly stated as an "In Vitro Diagnostic device" in the "Intended Use / Indications for Use" section. It identifies and enumerates lymphocyte subsets in human cells, which is a diagnostic purpose.
No
The device description explicitly states that the system is comprised of a flow cytometer, a wet cart, and a computer, indicating the presence of significant hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "The BD FACSCanto System with BD FACSDiva software is intended for use as an In Vitro Diagnostic device..."
- Purpose of Use: The intended use describes the device's function in identifying and enumerating lymphocyte subsets in human cells, which is a diagnostic process performed outside the body (in vitro).
- Clinical Setting: The intended user is specified as "clinical laboratories," which are typical settings for IVD use.
- Use with IVD Assays: The intended use also mentions "using previously cleared IVD assays for flow cytometry," further reinforcing its role within the IVD workflow.
N/A
Intended Use / Indications for Use
The BD FACSCanto System with BD FACSDiva software 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 wash sample preparation method for flow cytometry.
- . Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method.
- . Immunophenotyping of lymphocyte subsets including CD3CD8, CD3 CD4, CD3 CD16* and/or CD56*, CD3 -CD19*, and CD3*.
Product codes
GKZ
Device Description
The BD FACSCanto System with BD FACSDiva software is comprised of a flow cytometer, a wet cart, and a computer. The wet 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 sub-systems; fluidics, optics and electronics. It contains one software package for manual immunophenotyping and is compatible with the BD FACSLoader for automatic sample introduction.
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
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)
Accuracy Study: Based on NCCLS document EP9-A2. (September 2002). Results: The BD FACSCanto demonstrated comparable accuracy relative to the predicate.
Precision Study: Based on NCCLS document EP5-A. (February 1999). Results: The BD FACSCanto demonstrated acceptable system precision.
Carryover Study: 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 demonstrated acceptable system carryover.
Linearity Study: 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 demonstrated acceptable system linearity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Attachment D 510(k) Summary
BD FACSCanto System with BD FACSDiva software 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 K040725.
Submitter Information (21 CFR 807.92(a)(1))
Becton Dickinson Immunocytometry Systems Submitter: 2350 Qume Drive San Jose, CA 95131
- Contact: Kim Fonda Sr. Regulatory Affairs Specialist (408) 954-2329 (408) 954-2495 (FAX) kim fonda(@)bd.com
March 19, 2004 Summary date:
Device Name and Classification (21 CFR 807.92(a)(2))
BD FACSCanto™ System with BD FACSDiva™ software Name: Classification: Class II (21 CFR 864.5220), Automated differential cell counter
Substantially Equivalent / Predicate Device (21 CFR 807.92(a)(3))
The BD FACSCanto System with BD FACSDiva software is substantially equivalent to the BD FACSCalibur™ with 4-color option for immunophenotyping using SimulTEST reagents and associated software. FACSCalibur 4-color instrument was cleared with FACSComp Software and CaliBRITE Beads by the Center for Devices and Radiological Health, under K973483 on 2/17/98. The BD FACSCanto System with BD FACSDiva software and BD FACSCalibur have similar intended uses, measure the same sample types and have similar performance characteristics.
Device Description (21 CFR 807.92(a)(4))
The BD FACSCanto System with BD FACSDiva software is comprised of a flow cytometer, a wet cart, and a computer. The wet 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 sub-systems; fluidics, optics and electronics. It contains one software package for
1
manual immunophenotyping and is compatible with the BD FACSLoader for automatic sample introduction.
Intended Use (21 CFR 807.92(a)(5))
The BD FACSCanto System with BD FACSDiva software 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 wash sample preparation method for flow cytometry.
Technological Characteristics (21 CFR 807.92(a)(6))
The following summary table describes the similarities and differences between the BD FACSCanto and the BD FACSCalibur.
| Characteristic | FACSCalibur System
(predicate) | BD FACSCanto System with
BD FACSDiva software
(new family member) |
|----------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | For identification and enumeration
of leucocyte subsets in human cells in
suspension | For identification and
enumeration of lymphocyte
subsets in human cells in
suspension using a lyse wash
sample preparation method for
flow cytometry. |
| Device
classification and
product code | Automated Differential Cell Counter
21 CFR 864.5220
Product Code: GKZ | Same |
| Lasers | Blue—488 nm argon ion
Red—635 nm diode laser | 488 nm solid state
633 nm HeNe |
| Detectors | 1 FSC photodiode
1 SSC photomultiplier tube (PMT)
4 fluorescence detector PMTs | Same FSC
Same SSC
Same 4 plus 2 additional
fluorescence detector PMTs |
| Optics | FACSCalibur flow cell | Same |
| | Laser light delivered by mirrors, prisms
and lenses
Emitted light delivered by mirrors | Laser light delivered by fiber
optics, prisms and lasers
Emitted light delivered by
collection and fiber optics |
| Electronics | Analog | Digital |
| Automated sample
introduction | FACS Loader:
K953302, 11/20/95 | Same |
2
| Characteristic | FACSCalibur System
(predicate) | BD FACSCanto System with
BD FACSDiva software
(new family member) |
|-------------------|-----------------------------------|-------------------------------------------------------------------------|
| Computer platform | Macintosh | PC |
Performance Data (21 CFR 807.92(b)(1)and (2))
| Study | Study Design | Results |
|---|---|---|
| Accuracy | Based on NCCLS document EP9-A2. | |
| (September 2002) | The BD FACSCanto demonstrated | |
| comparable accuracy relative to the | ||
| predicate. | ||
| Precision | Based on NCCLS document EP5-A. | |
| (February 1999) | The BD FACSCanto 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 demonstrated | |
| acceptable system carryover. | ||
| Linearity | 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 demonstrated | |
| acceptable system linearity. |
Conclusions from Performance Data (21 CFR 807.92(b)(3))
.
The BD FACSCanto System with BD FACSDiva software demonstrates substantial equivalence
to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kim Fonda Sr. Regulatory Affairs Specialist Becton Dickinson Immunocytometry Systems 2350 Qume Drive
SEP 1 0 2004
San Jose, CA 95131
SEP 10 2004
K040725 Re: Trade/Device Name: BD FACSCanto System with BD FACSDiva software Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 4, 2004 Received: August 6, 2004
Dear Ms. Fonda
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 r ou mayy attols 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.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Attachment G Indications for Use Statement
Indications for Use
510(k) Number: K040725
Device Name: BD FACSCanto System with BD FACSDiva software
Indications for Use:
- . Immunophenotyping in clinical laboratories, using previously cleared IVD assays for flow cytometry that utilize the lyse wash sample preparation method.
- . Immunophenotyping of lymphocyte subsets including CD3CD8, CD3 CD4, CD3 CD16* and/or CD56*, CD3 -CD19*, and CD3*.
Clinical Significance:
- I For In Vitro Diagnostic Use.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use -AND/OR (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)
Division Sign-Off
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Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K040725
Becton Dickinson Immunocytometry Systems 510(k) Notification BD FACSCanto System 3/19/04 Replacement Page 9/7/04