Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- GKGCentrifuge, Hematocrit2Product Code
- GKMHand-Tally, Differential1Product Code
- GJGPipette, Quantitative, Hematology1Product Code
- GJWPipette, Pasteur1Product Code
- GKEOsmotic Fragility Testing1Product Code
- GGGGuaiac Reagent2Product Code
- GGXPipette, Sahli1Product Code
- GGYPipette, Diluting1Product Code
- GHCTube, Sedimentation Rate1Product Code
- GHOHemocytometer1Product Code
- GHYHematocrit, Tube, Rack, Sealer, Holder2Product Code
- GIOTube, Collection, Capillary Blood1Product Code
- GKWAggregometer, Platelet, Thrombokinetogram2Product Code
- GLGPlatelet Counting, Manual1Product Code
- JBXAggregrometer, Platelet2Product Code
- JBYAggregometer, Platelet, Photo-Optical Scanning2Product Code
- JBZStudy, Platelet Adhesive2Product Code
- JCADevice, Bleeding Time2Product Code
- JIOBlood, Occult, Colorimetric, In Urine2Product Code
- JIPBlood, Occult, Enzymatic Method, In Urine2Product Code
- JPHTest, Erythrocyte Sedimentation Rate1Product Code
- JPIDevice, Hematocrit Measuring2Product Code
- KHEReagent, Occult Blood2Product Code
- OOXAutomated Occult Blood Analyzer2Product Code
- OSLControl, Fecal Occult Blood2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
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Automated Occult Blood Analyzer
- Page Type
- Product Code
- Definition
- The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding.
- Physical State
- The system consists of an analyzer, test reagents (antibody, calibrators and controls) and collection devices containing buffer.
- Technical Method
- The test reagent contains an immunoassay utilizing monoclonal and polyclonal antibodies for human hemoglobin. A light beam measures the antibody reaction, i.e. the absorbance fo the reaction mixture measures the concentration of hemoglobin in the specimen.
- Target Area
- fecal samples
- Regulation Medical Specialty
- Hematology
- Review Panel
- Hematology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.6550
- 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 § 864.6550 Occult blood test
§ 864.6550 Occult blood test.
(a) Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)
(b) Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
[45 FR 60606, Sept. 12, 1980, as amended at 84 FR 71799, Dec. 30, 2019]