(144 days)
Not Found
No
The summary describes a standard flow cytometry system with software for manual and automatic immunophenotyping, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is an in vitro diagnostic (IVD) device used for identification and enumeration of lymphocyte subsets, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is intended for use as an In Vitro Diagnostic device for identification and enumeration of lymphocyte subsets in human cells".
No
The device description explicitly states that the system is comprised of a flow cytometer, a fluidics cart, and a computer, indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The very first sentence explicitly states: "The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device..." This is the most direct confirmation.
- Purpose: The intended use describes the device's function as "identification and enumeration of lymphocyte subsets in human cells in suspension." This is a diagnostic test performed on biological samples outside of the body, which is the definition of an in vitro diagnostic.
- Clinical Context: The intended use also mentions "Immunophenotyping in clinical laboratories," further reinforcing its use in a clinical diagnostic setting.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K973483) indicates that this device has gone through the regulatory process for medical devices, specifically likely a 510(k) submission, which is common for IVDs.
Therefore, based on the provided information, the BD FACSCanto System with BD FACSCanto software is clearly intended and used as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The BD FACSCanto System with BD FACSCanto 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 no-wash sample preparation method for flow cytometry.
Indications for Use:
- Immunophenotyping in clinical laboratories, using previously cleared IVD 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*
Product codes
GKZ
Device Description
The BD FACSCanto System with BD FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. 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 sub-systems; fluidics, optics and electronics. It contains two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Flow cytometry
Anatomical Site
Human cells in suspension (lymphocyte subsets)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratories / In Vitro Diagnostic Use
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:
- Study Design: Based on NCCLS document EP9-A2. (September 2002)
- Results: The BD FACSCanto with BD FACSCanto software demonstrated comparable accuracy relative to the predicate.
Precision Study:
- Study Design: Based on NCCLS document, EP5-A. (February 1999)
- Results: The BD FACSCanto with BD FACSCanto software demonstrated acceptable system precision.
Linearity Study:
- Study Design: Based on NCCLS document, EP6-A. (April 2003)
- Results: The BD FACSCanto with BD FACSCanto software demonstrated acceptable system linearity.
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
Image /page/0/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are black against a white background. The text "HEALTH & HL" and "SERVICES - USA" are arranged around the logo.
1 2004 OCT
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Kim Fonda Senior Regulatory Affairs Specialist Becton Dickinson Immunocytometry Systems 2350 Qume Drive San Jose, California 95131
K041074 Trade/Device Name: BD FACSCanto System with BD FACSCanto software Regulation Number: 21 CFR & 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 11, 2004 Received: August 13, 2004
Dear Ms. Fonda:
Re:
This letter corrects our signed letter of September 17, 2004, regarding the typo to the device name. 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 (OS) 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.
1
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, h
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
2
Attachment D 510(k) Summary
BD FACSCanto with BD FACSCanto 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 K041074.
Submitter Information (21 CFR 807.92(a)(1))
| Submitter: | Becton Dickinson Immunocytometry Systems |
|---|---|
| 2350 Qume Drive | |
| San Jose, CA 95131 |
- Kim Fonda Contact: Sr. Regulatory Affairs Specialist 、 (408) 954-2329 (408) 954-2495 (FAX) kim_fonda@bd.com
Summary date: April 22, 2004
Device Name and Classification (21 CFR 807.92(a)(2))
BD FACSCanto™ System with BD FACSCanto 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 FACSCanto software is substantially equivalent to the BD FACSCalibur™ with 4-color option for immunophenotyping using BD Multitest reagents and BD Multiset software. The BD 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 with BD FACSCanto 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 FACSCanto software is comprised of a flow cytometer, a fluidics cart, and a computer. The fluidics cart contains operational fluids, the
3
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 two software packages, one for manual immunophenotyping and one for automatic immunophenotyping, and is compatible with the BD FACS Loader for automatic sample introduction.
Intended Use (21 CFR 807.92(a)(5))
The BD FACSCanto System with BD FACSCanto software is intended for use as an In Vitro Diagnostic device for identification and cnumeration of lymphocyte subsets in human cells in suspension using a lyse no-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
(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 no-
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
Laser light delivered by mirrors, prisms
and lenses
Emitted light delivered by mirrors | Same
Laser light delivered by fiber
optics, prisms and lasers
Emitted light delivered by
collection and fiber optics |
4
:
| Characteristic | FACSCalibur System
(predicate) | BD FACSCanto System
(new family member) |
|----------------------------------|-------------------------------------|--------------------------------------------|
| Electronics | Analog | Digital |
| Automated sample
introduction | FACS Loader:
K953302
11/20/95 | Same |
| 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 with BD FACSCanto | |
| software demonstrated comparable | ||
| accuracy relative to the predicate. | ||
| Precision | Based on NCCLS document, EP5-A. | |
| (February 1999) | The BD FACSCanto with BD FACSCanto | |
| software demonstrated acceptable system | ||
| precision. | ||
| Linearity | Based on NCCLS document, EP6-A. | |
| (April 2003) | The BD FACSCanto with BD FACSCanto | |
| software demonstrated acceptable system | ||
| linearity. |
Conclusions from Performance Data (21 CFR 807.92(b)(3))
The BD FACSCanto System demonstrates substantial equivalence to the predicate device.
5
Attachment G Indications for Use Statement
Indications for Use
510(k) Number: K041074
Device Name: BD FACSCanto System with BD FACSCanto software
Indications for Use:
- s Immunophenotyping in clinical laboratories, using previously cleared IVD 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*
Clinical Significance:
- For In Vitro Diagnostic Use. i
X Prescription Use (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 | |
|---|---|
| ------------------- | -- |
Page
Diagnostic DeviceOffice of In Vitro Diagnostic Device Office tion and Safety
510(k) K041074
Becton Dickinson Immunocytometry Systems 510(k) Notification BD FACSCanto System with BD FACSCanto software 4/22/04 Replacement Page 9/7/04
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