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510(k) Data Aggregation
K Number
K013371Device Name
UBIT-IR300 INFRARED SPECTROMETRY SYSTEM
Manufacturer
OTSUKA PHARMACEUTICAL CO., LTD.
Date Cleared
2001-12-21
(71 days)
Product Code
JJQ, MSQ
Regulation Number
862.2300Why did this record match?
Product Code :
JJQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UBiT-IR300 Infrared Spectrometry System is an in vitro diagnostic device designed to measure changes in 1302 content in breath CO2 gas by infrared spectroscopic analysis. The system consists of the UBiT-IR300 Infrared Spectrophotometer, the UBiT-AS10 Autosampler, and Otsuka Breath Collection Bags.
The UBiT-IR300 Infrared Spectrometry System is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori (H. pylori) infection. The UBiT-IR300 System is suitable for use in both clinical laboratory and point-of-care settings.
Device Description
The UBiT-IR300 Infrared Spectrometry System is a compact analyzer designed for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacter pylori. The UBiT-IR300 measures absorption of breath gas by calculating the ratios of 13CO2/12CO2 for a reference breath gas and a sample breath gas. The difference between the ratios for the reference and sample breath gases is calculated to obtain the final measurement result, which is reported as △'3CO2 and expressed as delta per mil (%) or Delta Over Baseline (DOB).
The System consists of the following components:
- UBiT-IR300 Infrared Spectrophotometer -
- UBiT-AS10 Autosampler -
- Otsuka Breath Collection Bags -
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K Number
K980120Device Name
DIGENE DML 2000 MICROPLATE LUMINOMETER
Manufacturer
DIGENE CORP.
Date Cleared
1998-02-06
(24 days)
Product Code
JJQ, KHO
Regulation Number
862.2300Why did this record match?
Product Code :
JJQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digene DML 2000 Microplate Luminometer is intended to measure light that is emitted as a result of a chemiluminescent reaction. Assay results obtained using chemiluminescence technology in 96 well microplates are calculated and interpreted according to assay validation parameters.
Device Description
The DML 2000 is a microplate luminometer capable of reading chemiluminescence from opaque microplates. Chemiluminescence is the production of light from a chemical reaction. The luminometer is optimally designed for measurement of glow type luminescence. The luminometer is designed to be run and controlled by a personal computer connected via a serial RS-232 interface port. The instrument is simple in design with measurement taking place in 96-well microplates, where each well is presented to the detector by stepper motors moving the plate. The light is detected by a photomultiplier tube. The light is amplified and converted to an electrical signal which is detected by a sensitive electrical amplifier. The detected signals are converted to Relative Light Units (RLU) and are reported for each well of the microplate. Assay results are calculated and interpreted according to assay validation parameters.
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K Number
K973938Device Name
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
Manufacturer
SFRI, INC.
Date Cleared
1998-02-04
(112 days)
Product Code
JJQ
Regulation Number
862.2300Why did this record match?
Product Code :
JJQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
THE ALPHA 4 LS IS INTENDED TO AUTOMATE MICROTITER PLATE PROCESSOR AND READER THAT MEASURES THE LIGHT ABORBANCE OR LUMINESCENCE OF REACTION PRODUCTS IN EITHER MODE.
Device Description
ALPHA 4 LS Automated Microtiterplate Processor and Reader
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K Number
K974762Device Name
STAT TRACKS
Manufacturer
AWARENESS TECHNOLOGY, INC.
Date Cleared
1998-01-28
(40 days)
Product Code
JJQ
Regulation Number
862.2300Why did this record match?
Product Code :
JJQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This accessory program may be used by customers with the general purpose analyzer (K882938) who want to link their instrument to a PC for the purpose of transferring the data from the general purpose instrument to the PC, instead of having the data typed manually by a data entry person
Device Description
Stat Tracks is a dedicated software interface and reporting tool comparable to any other commercially available software. It is also comparable to manual writing, graphing, and filing.
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K Number
K962113Device Name
ANTHOS PHACTS VERSION MICROPLATE READER
Manufacturer
COLUMBIA BIOSCIENCE, INC.
Date Cleared
1996-11-05
(158 days)
Product Code
JJQ
Regulation Number
862.2300Why did this record match?
Product Code :
JJQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Anthos PhACTS 2010 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
Device Description
The Anthos PhACTS 2010, 2001 and its predicate devices all share the same principle of operation. Briefly, each device provides a light source which is focused to provide illumination of wells in a microtiter plate. A corresponding silicon-photodiodes measures the amount of light absorbed by the sample as the light passes through the microplate well. The respective well absorbance measurements is used by the data reduction software to yield a specific well absorbance value which in turn can yield a qualitative or quantitative assay result.
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K Number
K961183Device Name
CBI 7520 READER
Manufacturer
COLUMBIA BIOSCIENCE, INC.
Date Cleared
1996-08-02
(129 days)
Product Code
JJQ
Regulation Number
862.2300Why did this record match?
Product Code :
JJQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CBI 7520 Microplate Reader is intended to be used as a general purpose microplate photometer for clinical use.
Device Description
The CBI 7520 microplate reader employs an automatic transport mechanism to bring the individual microplate wells into position for reading. The device employs Tungsten halogen lamp as the light source. The device uses silicon-photodiodes to measure the light absorbance.
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K Number
K962166Device Name
ORIGEN ANALYZER
Manufacturer
IGEN, INC.
Date Cleared
1996-07-31
(57 days)
Product Code
JJQ
Regulation Number
862.2300Why did this record match?
Product Code :
JJQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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