(90 days)
No
The document describes a semi-automated fluorescence microscope system with dedicated software for enumerating fluorescently labeled cells. There is no mention of AI, ML, deep learning, or any related concepts in the intended use, device description, or performance studies. The system appears to rely on standard image processing and counting algorithms rather than AI/ML for cell enumeration.
No
The device is described as being "for in vitro diagnostic use" and is used to "enumerate fluorescently labeled cells" and for "analysis of rare cells that are isolated from biological fluids". These functions are diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly 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." This directly indicates its diagnostic purpose.
No
The device description explicitly states it is a "semi-automated fluorescence microscope" and includes hardware components like the analyzer, monitor, keyboard, mouse, and UPS, in addition to the software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly 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."
This statement clearly indicates that the device is intended to be used for diagnostic purposes on biological samples outside of the body (in vitro).
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). The system also supports an optional Remote Review Workstation, which consists of a dedicated computer with CELLTRACKS® software, monitor, keyboard and mouse. 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. The optional Remote Review Workstation provides the capability to review images and report results remotely.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence microscopy
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Laboratory management, 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
Non-clinical testing for the CELLTRACKS ANALYZER II® System included:
Unit/Integration/System Verification System Level Validation Description of Testing Stress Testing Regression Testing Control Cell/Sample Performance Validation Testing
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The information presented in the premarket notification demonstrates that the performance of the CELLTRACKS ANALYZER II® System (modified) is substantially equivalent to the predicate device. Conclusion of Equivalence was demonstrated through non-clinical functional testing for the modified device. The information presented in the premarket notification provides a reasonable assurance that the CELLTRACKS ANALYZER II® System (modified) is as safe and effective as the predicate device for the stated intended use.
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
Veridex, LLC. 1001 US Highway 202 Raritan, NJ 08869
Traditional 510(k)
CELLTRACKS ANALYZER II March 20, 2013
JUN 2 0 2013
.
8.0 510(K) SUMMARY
.
| Submitter's Name | Veridex, LLC |
|---|---|
| Address | 1001 US Highway 202 |
| Raritan, NJ 08869-0606 | |
| Telephone Number | |
| Fax Number | 908-927-4947 |
| 908-526-5059 | |
| Contact Person | Kimberly Prescott, Associate Director, Global Regulatory Affairs |
| Date: | March 20, 2013 |
| Name of the Device | CELLTRACKS ANALYZER II® System |
| Common or Usual | |
| Name | Immunomagnetic circulating cancer cell selection and enumeration system |
| Classification Name | Immunomagnetic circulating cancer cell selection and enumeration system |
| Device Class: II | |
| Product Code: NQI | |
| Regulation Number: 21 CFR 866.6020 | |
| Performance Standards | There are no performance standards promulgated for this device. |
| 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. | |
| Identification of the | |
| Legally Marketed | |
| Device | |
| (Predicate Device) | CELLTRACKS ANALYZER II® System |
| Name: Immunomagnetic circulating cancer cell selection and enumeration | |
| system | |
| Device Class: II | |
| Product Code: NQI | |
| Regulation Number: 21 CFR 866.6020 |
. . . .
1
Veridex, LLC. 1001 US Highway 202 Raritan, NJ 08869
510(k) Summary, continued 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). The system also supports an optional Remote Review Workstation, which consists of a dedicated computer with CELLTRACKS® software, monitor, keyboard and mouse. Use of this product requires training and should be used under the Device Description 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. The optional Remote Review Workstation provides the capability to review images and report results remotely. The CELLTRACKS ANALYZER 118 (modified) is substantially equivalent to the CELLTRACKS ANALYZER II® (current - K113181, December 12, 2011). There has been no change to intended use, fundamental scientific technology, mode of operations, or specimen type/identification. There are 2 main modifications to the current CELLTRACKS Comparison to ANALYZER II® (K118131, cleared December 12, 2011) that are Predicate Device included in this Traditional 510(k) submission: The CELLTRACKS ANALYZER II® Software has been modified . to version 2.6.0, and is present on both the CELLTRACKS ANALYZER 110 PC and the Remote Review Workstation PC. A Remote Review Workstation PC is now available, supporting . identical image review and result reporting functionality that is currently supported locally on the CELLTRACKS ANALYZER II®. Non-clinical testing for the CELLTRACKS ANALYZER II® System included: Unit/Integration/System Verification . System Level Validation Description of Testing . . Stress Testing Regression Testing ● Control Cell/Sample Performance Validation Testing .
2
Veridex, LLC. 1001 US Highway 202 Raritan, NJ 08869
Traditional 510(k) CELLTRACKS ANALYZER II® March 20, 2013
The information presented in the premarket notification demonstrates that the performance of the CELLTRACKS ANALYZER II® System (modified) is substantially equivalent to the predicate device. Conclusion of Equivalence was demonstrated through non-clinical functional testing for Testing the modified device. The information presented in the premarket notification provides a reasonable assurance that the CELLTRACKS ANALYZER II® System (modified) is as safe and effective as the predicate device for the stated intended use.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2013
VERIDEX, LLC C/O MS. KIMBERLY PRESCOTT ASSOCIATE DIRECTOR, GLOBAL REGULATORY AFFAIRS 1001 US HIGHWAY 202 RARITAN NJ 08869
Re: K130794
Trade/Device Name: CELLTRACKS ANALYZER II® System Regulation Number: 21 CFR 866.6020
Regulation Name: Immunomagnetic circulating cancer cell selection and enumeration
system
Regulatory Class: II Product Code: NQI Dated: June 10, 2013 Received: June 13, 2013
Dear Ms. Prescott:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact 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/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.gov/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/MedicalDevices/Resourcesfor You/Industrv/default.htm.
Sincerely yours.
Maria M. Chan -S
Maria M. Chan Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health
Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K130794
Device Name: CELLTRACKS ANALYZER II® System
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 × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH; Office of In Vitro Diagnostics and Radiological Health (OIR)
MariaMChan -S
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
K130794 510(k):