(179 days)
Not Found
No
The description focuses on the hardware (flow cytometer, lasers, reagents) and the biological process (immunophenotyping, fluorescence tagging). There is no mention of AI, ML, or any computational analysis beyond standard data processing for flow cytometry.
No
The device is used for identification and enumeration of cell subsets for in-vitro diagnostic purposes, not for direct therapeutic intervention or treatment of disease.
Yes
The "Intended Use / Indications for Use" section explicitly states "Clinical immunophenotyping using the CyAn DXD flow cytometer...for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets...For In-Vitro Diagnostic Use". This indicates it is used to diagnose or monitor medical conditions.
No
The device description clearly describes a "bench-top flow cytometer system" which is a physical hardware device. While it likely includes software for operation and data analysis, it is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "For In-Vitro Diagnostic Use".
- Nature of the Test: The device is used for "Clinical immunophenotyping" and "identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660". This involves analyzing biological samples (human peripheral whole blood) outside of the body to provide information for clinical purposes.
- Components: The description mentions using reagents (Dako MultiMix, Dako FluoroSpheres) and a flow cytometer to perform the analysis, which are typical components of an in vitro diagnostic system.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
The CyAn DxD Flow Cytometer with Summit™ software and user manual is intended for use as an In-Vitro Diagnostic device for identification and enumeration of the relative fraction of lymphocyte subsets in human peripheral whole blood using flow cytometry, i.e., identifies the relative percentages of CD4 and CD8 T-cells as demonstrated by gating on CD3 positive cells. TC-660, the three color combination, CD3, CD4 and CD8 is intended for use to identify the relative percentages of CD4 and CD8 positive T cells. Calibrators, Dako K0110 FluoroSpheres are intended for in vitro use on the Dako CyAn™ DXD flow cytometer with Summit™ software to adjust detector voltages and monitor daily instrument performance. CD3 FITC (Dako F0818), CD3 PE (R0810), and CD3 APC (C7225) single antibody-fluorochrome conjugates are intended to be used for setting fluorescence compensation parameters using automated compensation.
Clinical immunophenotyping using the CyAn DXD flow cytometer, a lyse wash sample preparation method, for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660. For In-Vitro Diagnostic Use.
Prescription Use
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
The Dako CyAn™ DXD device is a bench-top flow cytometer system relying on multiple (up to three) laser stimulation of fluorescence tagged lymphocytes. It is used with the Dako MultiMix, a triple color reagent; one each to CD3, CD4 and CD8, conjugated to fluorochromes APC(allophycocyanin), r-phycoerythrin, and fluorescein isothiocynate, which are balanced to identify the dual positive T-cell populations (CD3+CD4+ and CD3+CD8+) in peripheral blood lymphocytes. The instrument requires daily set-up with Dako FluoroSpheres consisting of a set of 5 bead populations having different fluorescent intensities and one non-fluorescent bead population. The combination of fluorochromes enables excitation by light of any wavelength from 365-650 nm. The CyAn DXD utilizes anti-human CD3 conjugated with FITC, RPE and APC to perform autocompensation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
flow cytometry
Anatomical Site
human peripheral whole blood
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance characteristics evaluated in support of the CVAn DXD and its associated components include results on linearity, precision, accuracy, specificity and carryover. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate devices listed above.
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.
B-D FACS Calibur, K974360, K961701, K955909, K964974, K973483
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
AUG 1 5 2006
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| The assigned 510(k) number is: | K060423 |
|---|---|
| Submitter: | Dako. |
| 6392 Via Real | |
| Carpinteria, CA 93013 | |
| PH. 805.566.6655 FX. 805.566.0866 | |
| Establishment registration number: 2022180 | |
| Contact: | Tiffany D. Almeroth, RAC |
| Manager, Regulatory Affairs | |
| PH. 805.566.3041 | |
| Date Summary Prepared: | May 12, 2006 |
| Device Name(s): | CyAn™ DXD with Summit™ Software |
| (Code CY204-30, CY205-30) | |
| MultiMix™ Triple-Colour Reagent (Code TC660) | |
| Anti-Human CD8/FITC | |
| Anti-Human CD4/RPE | |
| Anti-Human CD3/APC | |
| FluoroSpheres (Code K0110) | |
| Anti-human CD3 FITC (Code F0818) | |
| Anti-human CD3 RPE (Code R0810) | |
| Anti-human CD3 APC (Code C7225) | |
| Device Classification: | Class II, Automated Differential Cell Counter |
| 21 CFR 864.5220 | |
| Product code: GKZ | |
| Panel: | Hematology and Pathology Devices Panel |
| Division of Clinical Laboratory Devices. | |
| Predicate Devices: | B-D FACS Calibur, K974360 |
| Dako CD3/CD4 (FR875), K961701 | |
| Dako CD3/CD8 (FR881), K955909 | |
| Dako CD45/CD14 (FR700), K964974 | |
| BD CalBRITE Beads, K973483 |
Device Description:
The Dako CyAn™ DXD device is a bench-top flow cytometer system relying on
1
multiple (up to three) laser stimulation of fluorescence tagged lymphocytes. It is used with the Dako MultiMix, a triple color reagent; one each to CD3, CD4 and CD8, conjugated to fluorochromes APC(allophycocyanin), r-phycoerythrin, and fluorescein isothiocynate, which are balanced to identify the dual positive T-cell populations (CD3+CD4+ and CD3+CD8+) in peripheral blood lymphocytes. The instrument requires daily set-up with Dako FluoroSpheres consisting of a set of 5 bead populations having different fluorescent intensities and one nonfluorescent bead population. The combination of fluorochromes enables excitation by light of any wavelength from 365-650 nm. The CyAn DXD utilizes anti-human CD3 conjugated with FITC, RPE and APC to perform autocompensation.
Intended Use:
For In Vitro Diagnostic Use
| CyAn™ DXD | The CyAn DxD Flow Cytometer with Summit™ software and user
manual is intended for use as an In-Vitro Diagnostic device for
identification and enumeration of the relative fraction of lymphocyte
subsets in human peripheral whole blood using flow cytometry, i.e.,
identifies the relative percentages of CD4 and CD8 T-cells as
demonstrated by gating on CD3 positive cells. TC-660, the three color
combination, CD3, CD4 and CD8 is intended for use to identify the
relative percentages of CD4 and CD8 positive T cells. Calibrators, Dako
K0110 FluoroSpheres are intended for in vitro use on the Dako CyAn™
DXD flow cytometer with Summit™ software to adjust detector voltages
and monitor daily instrument performance. CD3 FITC (Dako F0818),
CD3 PE (R0810), and CD3 APC (C7225) single antibody-fluorochrome
conjugates are intended to be used for setting fluorescence
compensation parameters using automated compensation. |
| ----------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Substantial Equivalence:
The Dako CvAn™ DXD flow cytometer is substantially equivalent to the BD FACS Calibur whereby these instruments are used to identify and enumerate lymphocyte subsets using fluorescence qating and automated quality control algorithms. These products share similar technology and testing methodology. The additional parameters offered by the CvAn DXD for identification and enumeration over the predicate device does not introduce any new issues of safety and effectiveness.
Performance Characteristics:
Performance characteristics evaluated in support of the CVAn DXD and its associated components include results on linearity, precision, accuracy, specificity and carryover. Results of all testing conducted have demonstrated a substantial degree of equivalency to the predicate devices listed above.
Therefore, based on the information provided in this premarket notification, Dako
2
concludes that the devices listed above are safe, effective and substantially equivalent
to, their, respective, predicate, daviese, in the indivation in the institution in a to their respective predicate devices in substantant substantially equivalent
materials, operational principles, and intended materials, operational principles, and intended use.
:
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
:
:
.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol, with its wings forming a curved shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Tiffany D. Almeroth, RAC Manager, Regulatory Affairs Dako North America, Inc. 6392 Via Real Carpinteria, California 93013
AUG 1 5 2006
Re: K060423
Trade/Device Name: CyAn™ DXD Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: II Product Code: GKZ Dated: August 3, 2006 Received: August 8, 2006
Dear Ms. Almeroth:
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 indice increases in 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 provisions of ine Act.
I annual registerations of the Act include requirements for annual registration, isting 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 (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 80.97). 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 the Acc Illum the (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
lobetz Beckerh
Robert L. Becker, Jr., MD, Ph Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K060423
Device Name: CyAn™ DXD
Indications For Use:
Clinical immunophenotyping using the CyAn DXD flow cytometer, a lyse wash sample preparation method, for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660.
For In-Vitro Diagnostic Use
Prescription Use × (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign Off
Divisi
Page 1 of
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060423