CELLTRACKS ANALYER II

K113181 · Veridex, LLC · NQI · Dec 12, 2011 · Immunology

Device Facts

• Record ID: K113181
• Device Name: CELLTRACKS ANALYER II
• Applicant: Veridex, LLC
• Product Code: NQI · Immunology
• Decision Date: Dec 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 866.6020
• Device Class: Class 2

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.

Device Story

Device modification involving software upgrade from version 2.4 to 2.5.0; OS migration from Debian Linux 4 to Debian Linux 5; includes software anomaly resolutions, customer satisfaction features, and Danish language translations. Modification maintains fundamental scientific technology of previously cleared device. Verification and validation activities performed per design controls to ensure performance consistency.

Clinical Evidence

No clinical data; bench testing and software verification/validation only.

Technological Characteristics

Software-based device; OS upgraded from Debian Linux 4 to Debian Linux 5. Modification involves firmware/software update for anomaly resolution and feature enhancement.

Indications for Use

Indicated for in vitro diagnostic enumeration of fluorescently labeled, immunomagnetically selected and aligned cells from biological fluids (e.g., whole blood) in a laboratory setting.

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.

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

To: THE FILE

RE: DOCUMENT NUMBER k113181

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.
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 the an upgrade from version 2.4 software to version 2.5.0 software that 1) includes an updated version of the operating system form Debian Linux 4 to Debian Linux 5 that will support future software changes, 2) provides solutions to software anomalies, 3) contains new features to enhance customer satisfaction, 4) contains software text strings translations in Danish.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and the software verification and validation results provided indicate no substantial change in device 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 and the Indications for Use Enclosure.

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.