(45 days)
Not Found
No
The summary describes a semi-automated fluorescence microscope with software for image acquisition and analysis, but there is no mention of AI or ML technologies. The description of the algorithms remaining the same as the predicate device further suggests the absence of newly incorporated AI/ML.
No
The device is described as an in vitro diagnostic (IVD) device used for enumerating fluorescently labeled cells and analyzing rare cells from biological fluids. It does not exert any direct therapeutic action on a patient.
Yes
This device is explicitly stated to be "for in vitro diagnostic use." It is used to enumerate fluorescently labeled cells and analyze rare cells isolated from biological fluids, which are typical functions of diagnostic devices.
No
The device description explicitly states it is a semi-automated fluorescence microscope consisting of hardware components like the analyzer, computer, monitor, keyboard, mouse, and UPS, in addition to the 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: "This product is for in vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device."
- Function: The device is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells isolated from biological fluids (like whole blood). This process is a common technique used in laboratory settings for diagnostic purposes.
- Use with Specimen Preparation Equipment and Reagents: The description mentions it is used in conjunction with the CELLTRACKS® AUTOPREP® System and specific reagent kits, which are typical components of an in vitro diagnostic workflow.
- Supervision of Laboratory Management: The intended user is described as requiring training and working under the supervision of laboratory management, which is consistent with the use of IVD devices in a clinical laboratory setting.
Therefore, based on the provided information, the CELLTRACKS ANALYZER II® is intended and marketed for in vitro diagnostic use.
N/A
Intended Use / Indications for Use
The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product is for in vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.
Product codes
NQI
Device Description
The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS® software, monitor, keyboard, mouse and uninterruptible power supply (UPS). Use of this product requires training and should be used under the supervision of laboratory management.
The CELLTRACKS ANALYZER II® is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS® AUTOPREP® System, which automates and standardizes the sample preparation with specific reagent kits.
Mentions image processing
All of the algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving and the logic and interface to the PC remain the same.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluorescence microscope
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used under the supervision of laboratory management.
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)
Equivalence was demonstrated through software verification and validation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.6020 Immunomagnetic circulating cancer cell selection and enumeration system.
(a)
Identification. An immunomagnetic circulating cancer cell selection and enumeration system is a device that consists of biological probes, fluorochromes, and other reagents; preservation and preparation devices; and a semiautomated analytical instrument to select and count circulating cancer cells in a prepared sample of whole blood. This device is intended for adjunctive use in monitoring or predicting cancer disease progression, response to therapy, and for the detection of recurrent disease.(b)
Classification. Class II (special controls). The special control for this device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Immunomagnetic Circulating Cancer Cell Selection and Enumeration System.” See § 866.1(e) for availability of this guidance document.
0
Summary Information
510(k) Summary
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: ____________________________________________________________________________________________________________________________________________
| | 1. Submitter name, address, contact | Veridex, LLC
1001 U.S. Route 202
Raritan, NJ 08869
Contact Person: Patricia Hojnoski |
|--|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Preparation Date | Date Special 510(k) prepared: October 27, 2011 |
| | 3. Device name | Trade or Proprietary Name: CellTracks Analyzer II®
Common Name: System, immunomagnetic, circulating
cancer cell, enumeration
Classification Name: Immunomagnetic circulating cancer
cell selection and enumeration system. (21 CFR 866.6020,
Product Code NQI) |
| | 4. Predicate device | The predicate device is the CellTracks Analyzer II®
(K060110, March 16, 2006) |
1
510(k) Summary, Continued
:
| 5. Device Description | The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS® software, monitor, keyboard, mouse and uninterruptible power supply (UPS). Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II® is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS® AUTOPREP® System, which automates and standardizes the sample preparation with specific reagent kits. |
|---|---|
| 6. Device intended use | The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product is for in vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device. |
| 7. Comparison to predicate device | The CellTracks Analyzer II® (modified) is substantially equivalent to the CellTracks Analyzer II® (K060110: March 16, 2006). There has been no change to intended use, fundamental scientific technology, mode of operations, or specimen type/identification. All of the algorithms associated with image acquisition, analysis, cell selection, review, reporting and archiving and the logic and interface to the PC remain the same. Changes from the predicate include: Upgrade from version 2.4 software to version 2.5.0 software: The software will include the following design changes: |
CellTracks Analyzer II® 510(k) Summary Page 2 of 3
2
510(k) Summary, Continued
- -- Updated version of the operating system to support future hardware changes
- -- Solutions to software anomalies
- -- New features to enhance customer satisfaction
- -- Software text string translations to Danish
8. Conclusions
The information presented in the premarket notification demonstrates that the performance of the CellTracks Analyzer II® (modified) is substantially equivalent to the predicate device.
Equivalence was demonstrated through software verification and validation.
The information presented in the premarket notification provides assurance that the CellTracks Analyzer II® (modified) is safe and effective for the stated intended use. No new issues of safety or effectiveness have been raised.
CellTracks Analyzer II® 510(k) Summary
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a common symbol associated with health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Veridex, LLC c/o Patricia M. Hojnoski, MS, RAC Manager, Regulatory Affairs 1001 US Highway 202 North Raritan, NJ 08869
DEC 1 2 2011
Re: K113181
Trade Name: CellTracks Analyzer II® Regulation Number: 21 CFR §866.6020 Regulation Name: Immunomagnetic circulating cancer cell selection and enumeration system Regulatory Class: Class II Product Code: NQI Dated: November 28, 2011 Received: November 29, 2011
Dear Ms. Hojnoski:
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 class II (Special Controls), 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); medical device reporting of
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Page 2 - Ms. Patricia Hojnoski
medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip
)
6
Maria M. Chan, 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
Indications for Use
510(k) Number (if known): K11318
Device Name: CellTracks Analyzer II®
Indications For Use:
The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope used to enumerate fluorescently labeled cells that are immunomagnetically selected and aligned. This product is for in vitro diagnostic use when used in tandem with specimen preparation equipment and reagents that are legally marketed for in vitro diagnostic use with this device.
Prescription Use _ X (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
bon
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113181
Veridex, LLC
CellTracks Analyzer II®