Anesthesiology
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- MiscellaneousMiscellaneous
- PFXSystem, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection2Product Code
- PSUJak2 Gene Mutation Detection Test2Product Code
- QAZCancer Predisposition Risk Assessment System2Product Code
- QDIFish Based Detection Of Chromosomal Abnormalities From Patients With Hematologic Malignancies2Product Code
- MAODna-Probe, Human ChromosomeUProduct Code
- MKQProcessor, Cervical Cytology Slide, Automated3Product Code
- MNMReader, Cervical Cytology Slide, Automated3Product Code
- MTIKit, Cell Screening, FetalNProduct Code
- MVCSystem, Test, Her-2/Neu, Ihc3Product Code
- MVDSystem, Test, Her-2/Neu, Nucleic Acid Or Serum3Product Code
- NSDTest, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence3Product Code
- NXGFluorescence In Situ Hybridization, Topoisomerase Ii Alpha, Gene Amplification And Deletion3Product Code
- OQSLaboratory Developed TestNProduct Code
- OTUResearch Use Only/PathologyNProduct Code
- OWEFluorescence In Situ Hybridization, Anaplastic Lymphoma Kinase, Gene Rearrangement3Product Code
- PANBraf Mutation KitNProduct Code
- PDDInvestigational Use Only - PathologyNProduct Code
- PFUTissue Processing KitNProduct Code
- PHPSystem, Colorectal Neoplasia, Dna Methylation And Hemoglobin Detection3Product Code
- PJGCancer-Related Germline Gene Mutation Detection System3Product Code
- PKWImmunohistochemistry Assay, Antibody, Anaplastic Lymphoma Kinase3Product Code
- PLSImmunohistochemistry Assay, Antibody, Programmed Death-Ligand 13Product Code
- PQPNext Generation Sequencing Oncology Panel, Somatic Or Germline Variant Detection System3Product Code
- QFISynthetic Next-Generation Sequencing Quality Control And Filler MaterialNProduct Code
- QFKTumor Gene Profiling TestNProduct Code
- QQTImmunohistochemistry Assay, Antibody, Ki-673Product Code
- QSACirculating Tumor Cell (Ctc) Enrichment Device2Product Code
- QVUHigh Throughput Dna Sequencing For Hereditary Cancer Predisposition Assessment Test System.2Product Code
- QYVDigital Cervical Cytology Slide Imaging System With Artificial Intelligence Algorithm2Product Code
- SBBSystem, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection3Product Code
- SBYHigh Throughput Sequencing Based Tumor Profiling Test Of Circulating Cell-Free Nucleic Acids2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart D—Pathology Instrumentation and AccessoriesCFR Sub-Part
- Subpart E—Immunology Laboratory Equipment and ReagentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
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System, Colorectal Neoplasia, Rna Markers And Hemoglobin Detection
- Page Type
- Product Code
- Definition
- The colorectal neoplasia RNA and hemoglobin assay is a non-invasive, qualitative in vitro diagnostic intended for the detection of colorectal neoplasia associated RNA markers and for the presence of occult hemoglobin in human stool. The test is to aid in the detection of colorectal cancer (CRC) and advanced adenomas (AA). The test is not a replacement for diagnostic colonoscopy. It is indicated for use in adults 45 years or older, who are typical average-risk candidates for colorectal cancer (CRC) screening. A positive result may indicate the presence of CRC or AA and should be followed by a diagnostic colonoscopy.
- Physical State
- The device includes reagents, enzymes, and buffers to amplify and detect the assay targets. The test may include a specimen collection kit that may include a stool sample, collection bucket, and sample preservative
- Technical Method
- The test uses polymerase chain reaction (PCR) to evaluate eukaryotic ribonucleic acid (RNA) markers and the enzymatic detection of occult hemoglobin in conjunction with other clinical characteristics to assess the likely presence of colorectal cancer and advanced adenomas. A single result, positive or negative, is determined based on the combination of results. Based on the combined results of the RNA markers, hemoglobin and smoking status, a single result, positive or negative is determined.
- Target Area
- Human Clinical Specimens, Human Stool Samples
- Review Panel
- Pathology
- Submission Type
- PMA
- Device Classification
- Class 3
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
The FDA has not linked product code SBB to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:
- The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
- The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
- The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.