Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart C—Microbiology DevicesCFR Sub-Part
- Subpart D—Clinical Toxicology Test SystemsCFR Sub-Part
- Subpart D—Serological ReagentsCFR 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
- CZQBence-Jones Protein, Antigen, Antiserum, Control2Product Code
- CZRHemopexin, Rhodamine, Antigen, Antiserum, Control2Product Code
- CZSRetinol-Binding Protein, Antigen, Antiserum, Control1Product Code
- CZTHemopexin, Fitc, Antigen, Antiserum, Control2Product Code
- CZWComplement C3, Antigen, Antiserum, Control2Product Code
- CZXHemopexin, Antigen, Antiserum, Control2Product Code
- CZYComplement C1s, Antigen, Antiserum, Control2Product Code
- CZZHaptoglobin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DABHaptoglobin, Fitc, Antigen, Antiserum, Control2Product Code
- DACComplement C3b Activator, Antigen, Antiserum, Control2Product Code
- DADHaptoglobin, Antigen, Antiserum, Control2Product Code
- DAEComplement C9, Antigen, Antiserum, Control2Product Code
- DAFGamma Globulin, Fitc, Antigen, Antiserum, Control2Product Code
- DAGComplement C8, Antigen, Antiserum, Control2Product Code
- DAHGamma Globulin, Antigen, Antiserum, Control2Product Code
- DAIComplement C1r, Antigen, Antiserum, Control2Product Code
- DAJFree Secretory Component, Antigen, Antiserum, Control2Product Code
- DAKComplement C1q, Antigen, Antiserum, Control2Product Code
- DALFraction Iv-5, Antigen, Antiserum, Control1Product Code
- DAMHemoglobin, Chain Specific, Antigen, Antiserum, Control2Product Code
- DANFibrinopeptide A, Antigen, Antiserum, Control2Product Code
- DAOIgm (Mu Chain Specific), Antigen, Antiserum, Control2Product Code
- DAQIgg (Fd Fragment Specific), Antigen, Antiserum, Control1Product Code
- DASIgg (Fc Fragment Specific), Antigen, Antiserum, Control1Product Code
- CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)2Product Code
- CFNMethod, Nephelometric, Immunoglobulins (G, A, M)2Product Code
- CFQRadioimmunoassay, Immunoglobulins (G, A, M)2Product Code
- CGMMethod, Immunodiffusion, Immunoglobulins (G, A, M)2Product Code
- CHNImmunochemical, Ceruloplasmin2Product Code
- CZJIgd, Antigen, Antiserum, Control2Product Code
- CZKIga, Rhodamine, Antigen, Antiserum, Control2Product Code
- CZLIga, Peroxidase, Antigen, Antiserum, Control2Product Code
- CZMIga, Ferritin, Antigen, Antiserum, Control2Product Code
- CZNIga, Fitc, Antigen, Antiserum, Control2Product Code
- CZOInter-Alpha Trypsin Inhibitor, Antigen, Antiserum, Control1Product Code
- CZPIga, Antigen, Antiserum, Control2Product Code
- DAWAlpha-2-Ap-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DAYComplement C5, Antigen, Antiserum, Control2Product Code
- DBAComplement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control2Product Code
- DBCAlpha 2, 2n-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DBEAntismooth Muscle Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBFFerritin, Antigen, Antiserum, Control2Product Code
- DBHFc, Rhodamine, Antigen, Antiserum, Control1Product Code
- DBIComplement C4, Antigen, Antiserum, Control2Product Code
- DBJAntiparietal Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBKFc, Fitc, Antigen, Antiserum, Control1Product Code
- DBLMultiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBMAntimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DBNFc, Antigen, Antiserum, Control1Product Code
- DBYFab, Rhodamine, Antigen, Antiserum, Control1Product Code
- DCBFab, Fitc, Antigen, Antiserum, Control1Product Code
- DCEFab, Antigen, Antiserum, Control1Product Code
- DCFAlbumin, Antigen, Antiserum, Control2Product Code
- DCHSystem, Test, C-Reactive Protein, Rhodamine2Product Code
- DCJBeta-Globulin, Antigen, Antiserum, Control1Product Code
- DCKC-Reactive Protein, Antigen, Antiserum, And Control2Product Code
- DCNSystem, Test, C-Reactive Protein2Product Code
- DCOAlpha-Globulin, Antigen, Antiserum, Control1Product Code
- DCTCeruloplasmin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DCYCeruloplasmin, Fitc, Antigen, Antiserum, Control2Product Code
- DDBCeruloplasmin, Antigen, Antiserum, Control2Product Code
- DDCThyroglobulin, Antigen, Antiserum, Control2Product Code
- DDDTransferrin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDGTransferrin, Antigen, Antiserum, Control2Product Code
- DDITransferrin, Fitc, Antigen, Antiserum, Control2Product Code
- DDJThyroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDKBeta-2-Glycoprotein Iii, Antigen, Antiserum, Control1Product Code
- DDLThyroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDNBeta-2-Glycoprotein I, Antigen, Antiserum, Control1Product Code
- DDOMyoglobin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDRMyoglobin, Antigen, Antiserum, Control2Product Code
- DDSPrealbumin, Fitc, Antigen, Antiserum, Control1Product Code
- DDTAlpha-2-Macroglobulin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DDYAlpha-2-Macroglobulin, Fitc, Antigen, Antiserum, Control2Product Code
- DDZAlbumin, Fitc, Antigen, Antiserum, Control2Product Code
- DEAMyoglobin, Fitc, Antigen, Antiserum, Control2Product Code
- DEBAlpha-2-Macroglobulin, Antigen, Antiserum, Control2Product Code
- DECInter-Alpha Trypsin Inhibitor, Fitc, Antigen, Antiserum, Control1Product Code
- DEFAlpha-2-Hs-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEGLactoferrin, Antigen, Antiserum, Control1Product Code
- DEHLambda, Antigen, Antiserum, Control2Product Code
- DEIAlpha-1-Antitrypsin, Fitc, Antigen, Antiserum, Control2Product Code
- DEJAlpha-2-Glycoproteins, Antigen, Antiserum, Control1Product Code
- DEKKappa, Rhodamine, Antigen, Antiserum, Control2Product Code
- DELLipoprotein X, Antigen, Antiserum, Control1Product Code
- DEMAlpha-1-Antitrypsin, Antigen, Antiserum, Control2Product Code
- DENAlpha-1-T-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEOKappa, Fitc, Antigen, Antiserum, Control2Product Code
- DERAlpha-1-Lipoprotein, Antigen, Antiserum, Control2Product Code
- DESLambda, Fitc, Antigen, Antiserum, Control2Product Code
- DETLactic Dehydrogenase, Antigen, Antiserum, Control1Product Code
- DEWIgg, Antigen, Antiserum, Control2Product Code
- DEXAlpha-1-B-Glycoprotein, Antigen, Antiserum, Control1Product Code
- DEZIgm, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFBAlpha-1-Antitrypsin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFCLipoprotein, Low-Density, Antigen, Antiserum, Control2Product Code
- DFFAlpha-1-Antichymotrypsin, Antigen, Antiserum, Control2Product Code
- DFGLambda, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFHKappa, Antigen, Antiserum, Control2Product Code
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control1Product Code
- DFJAlbumin, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFKIgg (Fab Fragment Specific), Antigen, Antiserum, Control1Product Code
- DFLIgm, Ferritin, Antigen, Antiserum, Control2Product Code
- DFMIge, Ferritin, Antigen, Antiserum, Control2Product Code
- DFOIgg, Rhodamine, Antigen, Antiserum, Control2Product Code
- DFQSperm, Antigen, Antiserum, Control1Product Code
- DFSIgm, Fitc, Antigen, Antiserum, Control2Product Code
- DFTIgm, Antigen, Antiserum, Control2Product Code
- DFXSperm, Fitc, Antigen, Antiserum, Control1Product Code
- DFZIgg (Gamma Chain Specific), Antigen, Antiserum, Control2Product Code
- DGACohn Fraction Ii, Antigen, Antiserum, Control1Product Code
- DGCIge, Antigen, Antiserum, Control2Product Code
- DGDIgg, Ferritin, Antigen, Antiserum, Control2Product Code
- DGEIgd, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGGIgd, Fitc, Antigen, Antiserum, Control2Product Code
- DGIBreast Milk, Rhodamine, Antigen, Antiserum, Control1Product Code
- DGJColostrum, Antigen, Antiserum, Control1Product Code
- DGKIgg, Fitc, Antigen, Antiserum, Control2Product Code
- DGLIge, Rhodamine, Antigen, Antiserum, Control2Product Code
- DGMBreast Milk, Antigen, Antiserum, Control1Product Code
- DGNBreast Milk, Fitc, Antigen, Antiserum, Control1Product Code
- DGPIge, Fitc, Antigen, Antiserum, Control2Product Code
- DGWSystem, Test, Hypersensitivity Pneumonitis2Product Code
- DGXNg1m(A), Antigen, Antiserum, Control1Product Code
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological2Product Code
- DHCSystem, Test, Systemic Lupus Erythematosus2Product Code
- DHINg3m(Bo), Antigen, Antiserum, Control1Product Code
- DHNAntinuclear Antibody, Indirect Immunofluorescent, Antigen, Control2Product Code
- DHQNg3m(G), Antigen, Antiserum, Control1Product Code
- DHRSystem, Test, Rheumatoid Factor2Product Code
- DHYNg4m(A), Antigen, Antiserum, Control1Product Code
- JFQP-Phenyl-Enediamine/Edta (Spectrophotometric), Ceruloplasmin2Product Code
- JFRIndirect Copper Assay, Ceruloplasmin2Product Code
- JHRRadioimmunoassay, Immunoglobulins (D, E)2Product Code
- JKMImmunochemical, Bence-Jones Protein2Product Code
- JNLImmunochemical, Thyroglobulin Autoantibody2Product Code
- JNMImmunochemical, Transferrin2Product Code
- JZGSystem, Test, Beta-2-Microglobulin Immunological2Product Code
- JZHFactor B, Antigen, Antiserum, Control2Product Code
- JZJPrealbumin, Antigen, Antiserum, Control1Product Code
- JZOSystem, Test, Thyroid Autoantibody2Product Code
- KHTFraction V, Antigen, Antiserum, Control1Product Code
- KTLAnti-Dna Indirect Immunofluorescent Solid Phase2Product Code
- KTMC3-Indirect Immunofluorescent Solid Phase2Product Code
- KTOReagent, Immunoassay, Igg1Product Code
- KTPComplement C3b Activator Immunoassay Reagents2Product Code
- KTSSecond Antibody (Species Specific Anti-Animal Gamma Globulin)2Product Code
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls2Product Code
- LKJAntinuclear Antibody, Antigen, Control2Product Code
- LKLAlpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control1Product Code
- LKOAnti-Rnp Antibody, Antigen And Control2Product Code
- LKPAnti-Sm Antibody, Antigen And Control2Product Code
- LLLExtractable Antinuclear Antibody, Antigen And Control2Product Code
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control2Product Code
- LSWAnti-Dna Antibody, Antigen And Control2Product Code
- MGAAlpha-1 Microglobulin, Antigen, Antiserum, Control1Product Code
- MIDSystem, Test, Anticardiolipin Immunological2Product Code
- MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control2Product Code
- MLHStrip, Hama Igg, Elisa, In Vitro Test System2Product Code
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)2Product Code
- MQAAnti-Ribosomal P Antibodies2Product Code
- MSTAntibodies, Gliadin2Product Code
- MSVSystem,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)2Product Code
- MVEBiosensor, Immunoassay, Myoglobin2Product Code
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)2Product Code
- MVMAutoantibodies, Endomysial(Tissue Transglutaminase)2Product Code
- NBOAutoantibodies, Skin (Desmoglein 1 And Desmoglein 3)2Product Code
- NBSAutoantibodies, Lkm-1 (Liver/Kidney Microsome, Type 1)2Product Code
- NBTAntibodies, Saccharomyces Cerevisiae (S.Cerevisiae)2Product Code
- NHXAntibodies, Anti-Cyclic Citrullinated Peptide (Ccp)2Product Code
- NIYAutoantibodies, Anti-Soluble Liver Antigen (Sla), Autoimmune Hepatitis2Product Code
- NJFAntibodies, Anti-Actin, Anti-Smooth Muscle2Product Code
- NOETest, System, Immunoassay, Lipoprotein-Associated Phospholipase A22Product Code
- NPHAntigen, Cartilage Oligomeric Matrix Protein (Comp)2Product Code
- NQDCardiac C-Reactive Protein, Antigen, Antiserum, And Control2Product Code
- NRIAutoantibodies, Nuclear Pore Glycoprotein Gp2102Product Code
- NRXComplement 4d (C4d) And Complement Receptor 1 (Cr1)2Product Code
- NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking2Product Code
- NUMAutoantibodies, Nuclear Body Protein, Sp1002Product Code
- NWGAutoantibodies, Glutamic Acid Decarboxylase (Gad)2Product Code
- NXOCalprotectin, Fecal2Product Code
- NYOAutoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody2Product Code
- OBEAnti-Ss-A 52 Autoantibodies2Product Code
- OBZAlpha-1-Antitrypsin Kit, Qualitative Phenotype2Product Code
- OCNInsulin Autoantibody Kit2Product Code
- OEGAutoantibodies, Skin (Bullous Pemphigoid 180 And Bullous Pemphigoid 2302Product Code
- OIFTyrosine Phosphatase (Ia-2) Autoantibody Assay2Product Code
- OKMAntibodies, Outer-Membrane Proteins2Product Code
- OPNAuto-Antibodies; Phosphatidylserine, Prothrombin, Phosphatidylserine/Prothrombin Complex2Product Code
- OPXImmunoglobulin A Kappa Heavy & Light Chain Combined2Product Code
- OPYIgal Heavy & Light Chain Combined2Product Code
- OQZAnti-Mutated Citrullinated Vimentin Igg2Product Code
- OSKAnti-Glutamate Receptor (Type Nmda) Ifa2Product Code
- OYLTryptase Assay System2Product Code
- PAFVoltage Gated Calcium Channel (Vgcc) Antibody Assay2Product Code
- PCG21-Hydroxylase Antibody (21-Ohab)2Product Code
- PCNImmunoglobulin G Kappa Heavy And Light Chain Combined2Product Code
- PCOImmunoglobulin G Lambda Heavy And Light Chain Combined2Product Code
- PDEImmunoglobulin M Kappa Heavy And Light Chain Combined2Product Code
- PDFImmunoglobulin M Lambda Heavy And Light Chain Combined2Product Code
- PETAnti-Ss-A Ro60 Autoantibodies2Product Code
- PHFZinc Transporter 8 Auto-Antibody2Product Code
- PJISevere Combined Immunodeficiency Disorder (Scid) Newborn Screening Test System2Product Code
- PNIAquaporin-4 Autoantibody2Product Code
- PTAGenetic Variant Detection And Health Risk Assessment System2Product Code
- PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens2Product Code
- PZHSerpina1 Variant Detection System2Product Code
- QATBrain Trauma Assessment Test2Product Code
- NZBQuality Control Material, Genetics, Dna2Product Code
- QUKHuman Leukocyte Antigen (Hla) Typing Companion Diagnostic Test2Product Code
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Calprotectin, Fecal
- Page Type
- Product Code
- Definition
- The device is used for the measurement, in human stool, of fecal calprotectin, a neutrophilic protein that is a marker of mucosal inflammation. The device can be used as an aid in the diagnosis of inflammatory bowel disease (ibd), crohn's disease and ulcerative colitis and to differentiate ibd from irritable bowel syndrome.
- Physical State
- n/a
- Technical Method
- Enzyme-linked immunosorbent assay (ELISA)
- Target Area
- n/a
- Regulation Medical Specialty
- Immunology
- Review Panel
- Immunology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 866.5180
- 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 § 866.5180 Fecal calprotectin immunological test system
§ 866.5180 Fecal calprotectin immunological test system.
(a) Identification. A fecal calprotectin immunological test system is an in vitro diagnostic device that consists of reagents used to quantitatively measure, by immunochemical techniques, fecal calprotectin in human stool specimens. The device is intended forin vitro diagnostic use as an aid in the diagnosis of inflammatory bowel diseases (IBD), specifically Crohn's disease and ulcerative colitis, and as an aid in differentiation of IBD from irritable bowel syndrome.
(b) Classification. Class II (special controls). The special control for these devices is FDA's guidance document entitled “Class II Special Controls Guidance Document: Fecal Calprotectin Immunological Test Systems.” For the availability of this guidance document, see § 866.1(e).
[71 FR 42598, July 27, 2006]