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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
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
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Flow Cytometry Calibrator
- Page Type
- Product Code
- Definition
- Flow cytometer calibrators are polystyrene or other particles whose defined characteristics (e.g. number, size, scatter or fluorescence intensity) is used to standardize instrumentation or to quantify other particles or analytes measured by flow cytometers.
- Physical State
- Beads for performing absolute counts of cells in suspension by flow cytometry Beads for standardizing flow cytometers Beads that are used to calibrate fluorescence intensity to quantify ligand binding or fluorogenic assays performed by flow cytometry Beads that are used to perform calibration in addition to quality control of flow cytometric assays. SHOULD NOT INCLUDE beads that are only used for quality control
- Technical Method
- Bead associated fluorescence or scattered light is used to determine the number of other particles in solution ratio-metrically and to calibrate fluorescence intensity scales on a flow cytometer to standardize measures.
- Target Area
- Peripheral blood
- Regulation Medical Specialty
- Hematology
- Review Panel
- Immunology
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 864.5220
- 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 § 864.5220 Automated differential cell counter
§ 864.5220 Automated differential cell counter.
(a) Identification. An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.
(b) Classification. Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”
[67 FR 1607, Jan. 14, 2002]