FDA.reportPublic FDA data

POCone Infrared Spectrophotometer

Primary DI
04987035343417
Brand
POCone Infrared Spectrophotometer
Company
OTSUKA ELECTRONICS CO.,LTD.
Model
POCone
Device description
The POCone Infrared Spectrophotometer is an in vitro diagnostic device designed to measure changes in 13CO2 content in breath CO2 gas by infrared spectroscopic analysis.The POCone Infrared Spectrophotometer is intended for use in conjunction with commercially available Meretek 13C-urea breath tests for the detection of Helicobacterpylori (H. pylon) infection. The POCone Infrared Spectrophotometer is suitable for use in both point of care and clinical laboratory settings.
Published
2019-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JJQColorimeter, Photometer, Spectrophotometer For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJQColorimeter, Photometer, Spectrophotometer For Clinical UseClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041148000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041148000POCONE INFRARED SPECTROPHOTOMETEROtsuka Pharmaceutical Co., Ltd.2004-07-15MSQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04987035343417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04987035343417049870353434174987035343417

GMDN Terms#

Term, Definition table
TermDefinition
Infrared spectrometry breath analyser IVDAn electrically-powered laboratory or point-of-care instrument designed to use infrared spectrometry technology for the qualitative and/or quantitative in vitro determination of chemical and/or biological markers in a specimen of air exhaled from a patient. It is typically used to measure analytes such as ingested carbon isotopes that have been metabolized (e.g., 13C, 14C) to establish a correlation with metabolic profiles or disorders [e.g., gastrointestinal H. pylori infection]. The device operates with minimal technician involvement and complete automation of all procedural steps.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695318717
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04987035388517POC-AS10 Auto samplerPOC-AS102019-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00814905021479Safe Waste System Spectrophotometer for Pharmaceutical AnalysisCODONICS INC.JJQ2026-04-20
05430003908815SEEKER®Lacar MDX TechnologiesJJQ2026-01-15
00850049545501Diagnostic Automation, Inc.Diagnostic Automation, Inc.JJQ2025-12-24
00860011967750ZELLECHEM 200STERILE SAFEQUIP & CHEMICALS LLPJJQ2024-10-01
00816467020396FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816467020402FastPack® IP SystemQUALIGEN INC.JJQ2024-09-27
00816870020006NeoLumax CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020013LuMatic CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020051NeoEldex ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020068PrisMatic ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020075Autoplex G1 ELISA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870020082Autoplex G2 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
00816870024448Autoplex G3 ELISA + CLIA AnalyzerMONOBIND, INC.JJQ2024-09-13
07290016923063Auto Sampler (for BreathID Hp Lab System)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923384BreathID Hp Lab DeviceMERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
07290016923391BreathID Hp Lab Device (WIN)MERIDIAN BIOSCIENCE ISRAEL LTDJJQ2024-07-22
00860011967743ZELLECHEM-PROSTERILE SAFEQUIP & CHEMICALS LLPJJQ2024-07-09
04048474052527DRG:HYBRiD.XL®DRG Instruments Gesellschaft mit beschränkter HaftungJJQ2023-09-02
00840239052520DRG:HYBRiD.XL®DRG International IncJJQ2023-08-26
10810138822705EndocatorEndo Direct LLCJJQ2023-07-16
09120052071184SUNRISETecan Austria GmbHJJQ2023-07-06
09120052071191SUNRISE-RC/ST EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071207SUNRISE-RC/TW EVOLYZERTecan Austria GmbHJJQ2023-07-06
09120052071214SUNRISE-RC/6F EVOLYZERTecan Austria GmbHJJQ2023-07-06
06936895300151BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300212BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300229BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300236BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
06936895300243BIOBASEBiobase Biodustry(Shandong)Co., Ltd.JJQ2023-07-04
00850229007010StatFaxAWARENESS TECHNOLOGY, INCORPORATEDJJQ2023-06-05