(169 days)
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. Cell analyzers such as the CellTracks Analyzer II®, CellSpotter® System, flow cytometers or microscopes 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®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration following processing.
The 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.
The provided text describes a 510(k) premarket notification for the CellTracks® AutoPrep® System. This is a general purpose laboratory instrument for automated blood cell preparation, not an AI/ML powered diagnostic device. Therefore, much of the requested information (such as AI performance metrics, expert adjudication, MRMC studies, and training/test set details) is not applicable or cannot be extracted from this document.
However, I can extract the acceptance criteria related to its substantial equivalence to the predicate device and the study that demonstrates this.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (CellTracks® AutoPrep® System K040077) | Demonstrated through functional testing of the bulk fluid module and performance testing using quality control samples. |
| No change to intended use | Maintained. |
| No change to fundamental scientific technology | Maintained. |
| No change to mode of operations | Maintained. |
| No change to specimen type/identification | Maintained. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of AI/ML. The evaluation was based on "functional testing of the bulk fluid module" and "performance testing using quality control samples." The specifics of these samples (e.g., number, type, origin) are not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for AI/ML validation (e.g., expert consensus on images or pathology) is not relevant for this device's evaluation as it is a laboratory instrument, not an interpretive diagnostic.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is typically associated with expert review of diagnostic outputs, which is not described for this device.
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 device is a pre-analytic instrument, not an AI-powered diagnostic that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the instrument itself. The study mentioned "functional testing of the bulk fluid module" and "performance testing using quality control samples," which represents the standalone performance of the modified device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device would be the expected functional output and performance metrics based on established laboratory standards and comparisons to the predicate device. This is indicated by "functional testing" and "performance testing using quality control samples." The specific methodology for establishing these performance benchmarks is not detailed beyond these general terms.
8. The sample size for the training set
Not applicable. This device is an instrument, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Summary Information
AUG 2 6 2010
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: KJ00684
-
- Submitter name, address, contact
Veridex, LLC 1001 U.S. Route 202 Raritan, NJ 08869 Contact Person: Sarah McManus
- Submitter name, address, contact
-
Preparation Date 2.
-
- Device name
Date 510(k) prepared: March 9, 2010
Trade or Proprietary Name: CellTracks® AutoPrep® System Common Name: Blood cell diluting equipment Classification Name: Automated Blood Cell Diluting Apparatus (21 CFR 864.5240, Product Code GKH)
- Predicate device 4.
The predicate device is the CellTracks® AutoPrep® System (K040077, March 12, 2004)
{1}------------------------------------------------
5. Device Description
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®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration following processing.
The 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.
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. Cell analyzers such as the CellTracks Analyzer II®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
The CellTracks® AutoPrep® System (modified) is substantially equivalent to the CellTracks® AutoPrep® System (current -K040077: March 12, 2004). There has been no change to intended use, fundamental scientific technology, mode of operations, or specimen type/identification.
Changes from the predicate include:
-
- New make and model of waste bottle accessory.
- Labeling changes associated with the accessory waste 2) bottle and the waste bottle handling procedure.
CellTracks® AutoPrep® System 510(k) Summary
Comparison to predicate 7. device
Device intended use
{2}------------------------------------------------
8. Conclusions
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 functional testing of the bulk fluid module as well as performance testing using quality control samples.
The information presented in the premarket notification provides a reasonable assurance that the CellTracks® AutoPrep® System (modified) is safe and effective for the stated intended use.
CellTracks® AutoPrep® System 510(k) Summary
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle faces right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002
Veridex, LLC c/o Ms. Sarah McManus Manager, Regulatory Affairs 1001 US Highway 202 North Raritan, New Jersey 08869
AUG 2 6 2010
Re: K100684
Trade/Device Name: CellTracks® AutoPrep® System Regulation Number: 21 CFR 864.5240 Regulation Name: Automated blood cell diluting apparatus Regulatory Class: Class I Product Code: GKH Dated: July 23, 2010 Received: July 26, 2010
Dear Ms. McManus:
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 (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice
{4}------------------------------------------------
Page 2 - Ms. Sarah McManus
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.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,
ie mchan
Maria M. Chan, Ph.D. Director, Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Device and Radiological Health
Enclosure
{5}------------------------------------------------
Indication for Use
AUG 2 6 2010
510(k) Number (if known):
Device Name: CellTracks® AutoPrep® System
Indication For 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. Cell analyzers such as the CellTracks Analyzer II®, CellSpotter® System, flow cytometers or microscopes may be used for cell identification and enumeration. The system is for in vitro diagnostic use.
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)
is m chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 100 684
Veridex, LLC
CellTracks® AutoPrep® System
Page 1 of 1
ಷ
§ 864.5240 Automated blood cell diluting apparatus.
(a)
Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.