Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- 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
- DBTFactor Xiii A, S, Antigen, Antiserum, Control1Product Code
- DDECarbonic Anhydrase C, Antigen, Antiserum, Control1Product Code
- DDFProthrombin, Antigen, Antiserum, Control1Product Code
- DDHCarbonic Anhydrase B, Antigen, Antiserum, Control1Product Code
- DDXPlasminogen, Antigen, Antiserum, Control1Product Code
- DGBSeminal Fluid, Antigen, Antiserum, Control1Product Code
- DGQWhole Blood Plasma, Antigen, Antiserum, Control1Product Code
- DGRWhole Human Serum, Antigen, Antiserum, Control1Product Code
- KTKReagent, Immunoassay, Carbonic Anhydrase B And C1Product Code
- MVSKit, Typing, Hla-Dqb2Product Code
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- 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
- ImmunologyReview Panel
- 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
Prothrombin, Antigen, Antiserum, Control
- Page Type
- Product Code
- Regulation Medical Specialty
- Immunology
- Review Panel
- Hematology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 866.5735
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 866.5735 Prothrombin immunological test system
§ 866.5735 Prothrombin immunological test system.
(a) Identification. A prothrombin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prothrombin (clotting factor II) in serum. Measurements of the amount of antigenically competent (ability to react with protein antibodies) prothrombin aid in the diagnosis of blood-clotting disorders.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9. This exemption does not apply to multipurpose systems for in vitro coagulation studies classified under § 864.5425 of this chapter or prothrombin time tests classified under § 864.7750 of this chapter.
[47 FR 50823, Nov. 9, 1982, as amended at 65 FR 2313, Jan. 14, 2000]