(90 days)
The CELLTRACKS® AUTOPREP® System is a laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS ANALYZER II® may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
The CELLTRACKS® AUTOPREP® System is a general purpose laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS® AUTOPREP® System processes up to 8 samples in a batch, performing all required process steps, including red cell detection, plasma aspiration and final transfer to the analysis cartridge. The user is prompted to perform various pre-processing operations such as dilution and centrifugation. Cell analyzers such as the CELLTRACKS ANALYZER II® may be used for cell identification and enumeration following processing. The CELLTRACKS® AUTOPREP® system uses a series of immunomagnetic separation procedures to isolate the cells of interest and to stain the cells with fluorescence-labeled monoclonal antibodies.
This is a 510(k) summary for the CELLTRACKS® AUTOPREP® System, a medical device for in vitro diagnostic use. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (CELLTRACKS® AUTOPREP® System (current - K110406)). The only change is a modification to the pipetting probe to reduce potential carryover and a corresponding label change.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria for carryover. Instead, it focuses on demonstrating equivalence to the predicate device and characterization of the new probe's performance regarding carryover.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| New reagent probe assay performance equivalent to current probe. | Equivalence demonstrated through non-clinical functional testing. |
| Reduced potential for carryover compared to predicate device. | CTC spike level characterization of the new probe (tumor cell carryover and control cell carryover) was performed. Run to Run carryover characterization was performed. |
| Device is safe and effective as the predicate device. | Demonstrated through non-clinical functional testing for the modified device. |
| Reliability/Life testing requirements are met. | Reliability/Life testing was performed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set in terms of the number of patient samples. It mentions "up to 8 samples in a batch" for processing but this refers to the operational capacity of the instrument, not the sample size of the study for performance validation.
- Test Set Sample Size: Not explicitly stated for each test, but "up to 8 samples in a batch" is mentioned for processing.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The testing is described as "Non-clinical functional testing," implying laboratory-based testing rather than patient data collection in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is an automated instrument for processing and enriching cells. The evaluation appears to be based on analytical performance metrics (e.g., carryover levels, assay performance equivalence) rather than expert interpretation of images or patient data. Therefore, there's no mention of experts establishing ground truth for the test set in this context.
4. Adjudication method for the test set
Not applicable, as there are no human interpretations or classifications that would require adjudication. The testing is focused on the device's functional performance.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted diagnostic device that involves human readers. It's an automated sample preparation system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone product. The CELLTRACKS® AUTOPREP® System is a standalone instrument for sample preparation. The performance evaluation described is of the instrument's functional characteristics (e.g., pipetting, carryover), which is inherently "standalone" in its operation relative to the manual methods it automates. The "algorithm" in this context would be the automated processing steps of the instrument.
7. The type of ground truth used
The "ground truth" for this device would be defined by the expected analytical performance. For example:
- Known Cell Spikes: For CTC spike level characterization, a known number of tumor cells would be "spiked" into samples, and the device's ability to recover them, and the level of carryover from these known spikes, would be measured.
- Control Cells: For control cell carryover, known control cells would be used.
- Reference Methods: The "new reagent probe versus current reagent probe assay performance equivalence" would imply comparison to assays run with the predicate device's probe, where the "truth" is the established performance of the predicate.
- Engineering Specifications: Reliability/Life testing would be against pre-defined engineering specifications for durability and performance over time.
Therefore, the ground truth is based on analytical standards, known input concentrations (e.g., spiked cells), and comparison to a well-characterized predicate device's performance.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a "training set." It's an automated instrument where the "learning" is incorporated during its design and engineering phases, not through a data-driven training process.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Ki22821
8.0 510(K) SUMMARY
DEC 1 3 2012
1 -
| Submitter's Name | Veridex, LLC |
|---|---|
| Address | 1001 US Highway 202Raritan, NJ 08869-0606 |
| Telephone NumberFax Number | 908-927-4947908-526-5059 |
| Contact Person | Kimberly Prescott, Associate Director, Global Regulatory Affairs |
| Date: | December 6, 2012 |
| Name of the Device | CELLTRACKS® AUTOPREP® System |
| Common or UsualName | Automated Blood Cell Diluting Apparatus |
| Name: Immunomagnetic circulating cancer cell selection and enumerationsystem | |
| Classification Name | 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® AUTOPREP® System is a laboratory instrumentused with immunomagnetic reagents that capture and enrich target cells,and labeling reagents that differentiate cells in whole blood.The CELLTRACKS ANALYZER II® may be used for cell identificationand enumeration. The system is for in vitro diagnostic use. |
| CELLTRACKS® AUTOPREP® System | |
| Identification of theLegally MarketedDevice(Predicate Device) | Name: Immunomagnetic circulating cancer cell selection and enumerationsystemDevice Class: IIProduct Code: NQIRegulation Number: 21 CFR 866.6020 |
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510(k) Summary, continued
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| Device Description | The CELLTRACKS® AUTOPREP® System is a general purposelaboratory instrument used with immunomagnetic reagents that captureand enrich target cells, and labeling reagents that differentiate cells inwhole blood. The CELLTRACKS® AUTOPREP® System processesup to 8 samples in a batch, performing all required process steps,including red cell detection, plasma aspiration and final transfer to theanalysis cartridge. The user is prompted to perform various pre-processing operations such as dilution and centrifugation. Cellanalyzers such as the CELLTRACKS ANALYZER II® may be usedfor cell identification and enumeration following processing.The CELLTRACKS® AUTOPREP® system uses a series ofimmunomagnetic separation procedures to isolate the cells of interestand to stain the cells with fluorescence-labeled monoclonal antibodies. |
|---|---|
| Comparison toPredicate Device | The CELLTRACKS® AUTOPREP® System (modified) issubstantially equivalent to the CELLTRACKS® AUTOPREP®System (current - K110406, January 20, 2012). There has been nochange to intended use, fundamental scientific technology, mode ofoperations, or specimen type/identification.The only change from the predicate device and subject of this Special510(k) is a modification to the pipetting probe to reduce the potentialfor carryover, and a label change to the CELLTRACKS®AUTOPREP® System labeling to change the caution about carryoverfrom circulating tumor cell (CTC) samples when containing 5,000CTCs or greater per 7.5mL of blood. |
| Description of Testing | Non-clinical testing for the CELLTRACKS® AUTOPREP® Systemfunctional testing included:• New reagent probe versus current reagent probe assayperformance equivalence• CTC (circulating tumor cell) spike level characterization of thenew probe (tumor cell carryover and control cell carryover)• Run to Run carryover characterization• Reliability/Life testing |
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Image /page/2/Figure/0 description: The image shows the words "Conclusion of Testing" in a large, bold font. The text is located on the left side of the image. The background of the image is white with some light gray spots.
The information presented in the premarket notification demonstrates that the performance of the CELLTRACKS® AUTOPREP® System (modified) is substantially equivalent to the predicate device.
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® AUTOPREP® System (modified) is as safe and effective as the predicate device for the stated intended use.
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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 caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Letter Date: December 13, 2012
Veridex, LLC C/O Ms. Kimberly Prescott. 1001 US Highway 202 Raritan, NJ 08869-1424
| Re: 510(k) Number: | K122821 |
|---|---|
| Trade/Device Name: | CELLTRACKS AUTOPREP® System |
| 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 8, 2012 |
| Received: | November 9, 2012 |
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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Ms. Kimberly Prescott
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.
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 Diagnostics and Radiological Health 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.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/cdrh/industry/support/index.html.
Sincerely yours,
Reena Philip -S
for
Maria M. Chan, Ph.D.
Director
Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K122821
Device Name: CELLTRACKS® AUTOPREP® System
Indications for Use:
The CELLTRACKS® AUTOPREP® System is a laboratory instrument used with immunomagnetic reagents that capture and enrich target cells, and labeling reagents that differentiate cells in whole blood. The CELLTRACKS ANALYZER II® may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
Over-The-Counter Use Prescription Use X AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
mier lamp
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510K K122
§ 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.