Anesthesiology
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- MiscellaneousMiscellaneous
- 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
- NQISystem, Immunomagnetic, Circulating Cancer Cell, Enumeration2Product Code
- NYIClassifier, Prognostic, Recurrence Risk Assessment, Rna Gene Expression, Breast Cancer2Product Code
- OVQChronic Lymphocytic Leukemia Fish Probe Kit2Product Code
- OWKEarly Growth Response 1 (Egr) Fish Probe Kit2Product Code
- OWMProstate-Specific Antigen (Psa) For Prognostic, Recurrence Risk Assessment Of Prostate Cancers2Product Code
- OXPDna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment2Product Code
- OYXBcr/Abl1 Monitoring Test2Product Code
- QNCWhole Exome Sequencing Constituent Device2Product Code
- PZMNext Generation Sequencing Based Tumor Profiling Test2Product Code
- QDCDna-Based Test For Minimal Residual Disease For Hematologic Malignancies2Product Code
- 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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Dna-Probe Kit, Human Chromosome X And Y, Bmt Engraftment
- Page Type
- Product Code
- Definition
- X/Y DNA probe kit is intended to detect alpha satellite sequences in the centromere of chromosome (Chr) X and satellite III DNA at Yq12 of Chr Y along with routine diagnostic cytogenetic testing. It is indicated for use as an adjunct to standard cytogenetic analysis for identifying and enumerating Chr X and Y via FISH in interphase nuclei and metaphase spreads obtained from bone marrow (BM) specimens in recipients of opposite-sex BM transplantation (BMT) for hematological disorders. It is not intended to be used as a stand alone assay for test reporting; in subjects with like-sex BMT; in diagnostic testing or screening for constitutional X and Y Chr aneuploidies.
- Physical State
- Reagents for monitoring engraftment of sex mismatched bone marrow transplantation for hematological disorders
- Technical Method
- fluorescence in situ hybridization (FISH)
- Target Area
- opposite-sex bone marrow transplantation for hematological disorders
- Regulation Medical Specialty
- Immunology
- Review Panel
- Pathology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.6010
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.6010 Tumor-associated antigen immunological test system
§ 866.6010 Tumor-associated antigen immunological test system.
(a) Identification. A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
(b) Classification. Class II (special controls). Tumor markers must comply with the following special controls: (1) A guidance document entitled “Guidance Document for the Submission of Tumor Associated Antigen Premarket Notifications (510(k)s) to FDA,” and (2) voluntary assay performance standards issued by the National Committee on Clinical Laboratory Standards.
[62 FR 66005, Dec. 17, 1997]