This is a brief overview of information related to FDA’s clearance to market this product.
Product Name: CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer
Applicant: Veridex, LLC, A Johnson and Johnson company
Address: 1001 US HWY 202, Raritan, New Jersey 08869-0606
Clearance Date: January 21, 2004 (Approved Evaluation of Automatic Class III Designation)
Clearance Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf3/k031588.pdf
What is it? The CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer are used on breast cancer patients to help determine the effectiveness of their cancer treatment.
The CellSearch™ Epithelial Cell Kit helps a medical professional find Circulating Tumor Cells (CTC) in a blood sample. The CTC are then counted by a pathologist with the aid of the CellSpotter™ Analyzer. The more CTC in the blood sample, the less effective the cancer treatment is.
How does it work?
- A sample of blood is drawn from the patient and treated with the CellSearch™ Epithelial Cell Kit.
- Tiny, protein-coated magnetic balls mark the cancerous cells.
- The candidate cells are stained with fluorescent markers for precise identification.
- The labeled sample is dispensed into a cartridge for analysis.
- A strong magnetic field is applied to the mixture, causing magnetically marked cells to move to the cartridge surface.
- The cartridge is then analyzed by the CellSpotter™ Analyzer.
- The CellSpotter™ Analyzer presents the CTC to a medical professional who rechecks their identification, and the CellSpotter™ Analyzer tallies the final CTC count.
- The more CTC in the sample, the less effective the cancer treatment is.
When is it used? The CellSearch? ™ Epithelial Cell Kit / CellSpotter?™ Analyzer are used for patients undergoing treatment for breast cancer. The presence of CTC in the blood is associated with decreased survival in patients treated for spreading (metastatic) breast cancer.
What will it accomplish? The CellSearch™ Epithelial Cell Kit / CellSpotter™ Analyzer monitors breast cancer treatment and indicates its effectiveness.
When should it not be used? There are no contraindications for these devices.