(179 days)
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
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 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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Dako CyAn™ DXD device:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for performance metrics like precision, accuracy, specificity, or linearity. Instead, it makes a general statement about the study's findings:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Linearity | Not explicitly stated | Results demonstrated a "substantial degree of equivalency" to predicate devices. |
| Precision | Not explicitly stated | Results demonstrated a "substantial degree of equivalency" to predicate devices. |
| Accuracy | Not explicitly stated | Results demonstrated a "substantial degree of equivalency" to predicate devices. |
| Specificity | Not explicitly stated | Results demonstrated a "substantial degree of equivalency" to predicate devices. |
| Carryover | Not explicitly stated | Results demonstrated a "substantial degree of equivalency" to predicate devices. |
Important Note: The document focuses on demonstrating substantial equivalence to predicate devices rather than meeting specific quantitative performance targets. This is a common approach in 510(k) submissions.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It only mentions "Results of all testing conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or how ground truth was established for the test set. For a flow cytometer, the "ground truth" would typically be derived from the instrument's own measurements or comparison to a gold standard method.
4. Adjudication Method for the Test Set
Since the document does not mention the use of experts to establish a ground truth or subjective assessments, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The device is an automated differential cell counter, which typically doesn't involve human readers in the same way an imaging AI would.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, implicitly. The study evaluates the "Performance characteristics evaluated in support of the CVAn DXD and its associated components." This implies the performance of the device itself, including its automated algorithms for identification and enumeration of lymphocyte subsets, in a standalone manner. The device is a "bench-top flow cytometer system" with "Summit™ software" and "automated quality control algorithms."
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used. However, given the nature of a flow cytometer that measures cell populations, the "ground truth" would likely be:
- Reference standard measurements: Comparison to established flow cytometry methods or other validated laboratory techniques for cell counting and phenotyping.
- Intra-device consistency: Demonstrating that the device consistently identifies and enumerates cell populations.
The claim of "substantial degree of equivalency to the predicate devices" suggests that the predicate devices themselves served as a de facto "ground truth" or a benchmark for comparison.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This device is a flow cytometer for direct measurement and analysis, not an AI/machine learning model in the contemporary sense that typically requires a separate training set for model development. The software (Summit™) and algorithms are likely part of the device's inherent design and calibration, rather than being "trained" on a specific dataset in the modern ML context.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned in the context of an AI/ML model, the document does not describe how ground truth for a training set was established.
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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 RealCarpinteria, CA 93013PH. 805.566.6655 FX. 805.566.0866Establishment registration number: 2022180 |
| Contact: | Tiffany D. Almeroth, RACManager, Regulatory AffairsPH. 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/FITCAnti-Human CD4/RPEAnti-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 Counter21 CFR 864.5220Product code: GKZ |
| Panel: | Hematology and Pathology Devices PanelDivision of Clinical Laboratory Devices. |
| Predicate Devices: | B-D FACS Calibur, K974360Dako CD3/CD4 (FR875), K961701Dako CD3/CD8 (FR881), K955909Dako CD45/CD14 (FR700), K964974BD CalBRITE Beads, K973483 |
Device Description:
The Dako CyAn™ DXD device is a bench-top flow cytometer system relying on
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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 usermanual is intended for use as an In-Vitro Diagnostic device foridentification and enumeration of the relative fraction of lymphocytesubsets in human peripheral whole blood using flow cytometry, i.e.,identifies the relative percentages of CD4 and CD8 T-cells asdemonstrated by gating on CD3 positive cells. TC-660, the three colorcombination, CD3, CD4 and CD8 is intended for use to identify therelative percentages of CD4 and CD8 positive T cells. Calibrators, DakoK0110 FluoroSpheres are intended for in vitro use on the Dako CyAn™DXD flow cytometer with Summit™ software to adjust detector voltagesand monitor daily instrument performance. CD3 FITC (Dako F0818),CD3 PE (R0810), and CD3 APC (C7225) single antibody-fluorochromeconjugates are intended to be used for setting fluorescencecompensation 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
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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.
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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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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
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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
§ 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.”