CELLTRACKS AUTOPREP SYSTEM

K122821 · Veridex, LLC · NQI · Dec 13, 2012 · Immunology

Device Facts

• Record ID: K122821
• Device Name: CELLTRACKS AUTOPREP SYSTEM
• Applicant: Veridex, LLC
• Product Code: NQI · Immunology
• Decision Date: Dec 13, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6020
• Device Class: Class 2

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.

Device Story

Laboratory instrument for processing whole blood samples; utilizes immunomagnetic separation to capture and enrich target cells; performs automated steps including red cell detection, plasma aspiration, and transfer to analysis cartridge; requires user-performed pre-processing (dilution, centrifugation); stains cells with fluorescence-labeled monoclonal antibodies; used in clinical laboratories by trained personnel; output consists of processed samples in cartridges for subsequent identification and enumeration by CELLTRACKS ANALYZER II®; modification to pipetting probe reduces carryover risk; aids in clinical assessment of circulating tumor cells.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through non-clinical functional testing, including reagent probe performance equivalence, CTC spike level characterization (carryover assessment), run-to-run carryover characterization, and reliability/life testing.

Technological Characteristics

Automated sample preparation system. Modification: pipetting probe with extrude-honed ID and Teflon-coated ID/OD. Fundamental scientific technology unchanged from predicate. No changes to assay detection.

Indications for Use

Indicated for use in laboratory settings to capture, enrich, and label target cells in whole blood samples for subsequent identification and enumeration via the CELLTRACKS ANALYZER II®.

Regulatory Classification

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.

Special Controls

The device is classified as Class II under regulation 21 CFR 866.6020 with special controls. The special control guidance document "Immunomagnetic Circulating Cancer Cell Selection and Enumeration System" is available at https://www.fda.gov/cdrh/oivd/guidance/1531.pdf

*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.

Predicate Devices

• CELLTRACKS® AUTOPREP® System (K110406)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIR Review Memorandum (Decision Making Document is Attached)

To: THE FILE

RE: DOCUMENT NUMBER k122821

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable

1. The name and 510(k) number of the SUBMITTER'S previously cleared device.
CELLTRACKS® AUTOPREP® System (K110406)

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for:
a. Modification to the pipetting probe to reduce the potential for carryover;
b. A label change to the CELLTRACKS AUTOPREP System labeling to change the caution about carryover from circulating tumor cell (CTC) samples when containing 5,000 CTCs or greater per 7.5mL of blood..

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance.

Similarities:
| Feature | Modified Device |
| --- | --- |
| Intended Use | No Change |
| Fundamental Scientific Technology | No Change |
| Design Assay Detection | No Change |

Differences:
The design change includes the additional steps to extrude hone the probe ID followed by applying a Teflon coating to both the ID and OD.

Probes fabricated using extrude honing and Teflon coating were tested to demonstrate reduced cell carryover performance.

5. A Design Control Activities Summary which includes:
a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis)
b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied
c) A declaration of conformity with design controls. The declaration of conformity should include:
i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and
ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

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The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.