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510(k) Data Aggregation
K Number
K962762Device Name
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
Manufacturer
BIOTRACES, INC.
Date Cleared
1996-08-16
(31 days)
Product Code
JJJ
Regulation Number
862.2320Why did this record match?
Product Code :
JJJ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SSMPD is intended as a general use clinical laboratory gamma radiation counter. The SSMPD is designed for use by operators qualified to measure gamma-ray emissions from radiolabelled reagents within particular energy bands or energy regions of interest (ROI) as part of diagnostic radioassay or radioimmunoassay methods. The standard quantitative units of measure reported are the measured count per minute (cpm) and the calculated disintegrations per minute (dpm).
Device Description
The ssMPD is a twelve sample, bench-top gamma radiation counter that can be used to measure counts per minute and calculate disintegrations per minute emitted by multi-photon emission isotopes, including 125I. In volumes of 0.05 to 2.0 mls contained in 12 mm x 75 mm or 13 mm x 100 mm sample tubes disintegrations are measured over the range of 1 to 106 dpms. The sample tubes must be capped to minimize the possibility of contaminating the detector chamber. The full detector assembly is a twin detector system consisting of two scintillator crystals--each coupled to a high resolution planar photomultiplier. The entire detector is encased in a composite lead-tin-copper shield to minimize environmental background. In addition to permitting efficient counting of gamma emitters, the sample holder acts as a separator to reduce crosstalk within the twin scintillator detector assembly. The complete SSMPD system is comprised of a standalone SSMPD connected directly to a personal computer (PC) configured with SSMPD read-out electronics, MPDATA™ control and data logger software, and optionally, a printer.
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