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510(k) Data Aggregation
K Number
K141925Device Name
TOTAL PROTEIN URINE/CSF GEN.3
Manufacturer
Roche Diagnostics Operations (RDO)
Date Cleared
2014-12-09
(146 days)
Product Code
JIQ, JIO
Regulation Number
862.1645Why did this record match?
Product Code :
JIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
In vitro test for the quantitative determination of the total protein concentration in urine and cerebral spinal fluid.
Protein measurements in urine are used in the diagnosis and treatment of disease conditions such as renal or heart diseases, or thyroid disorders.
CSF protein measurements are used in the diagnosis and treatment of conditions such as meningitis, brain tumors, and infections of the central nervous systems.
Device Description
The Total Protein Urine/CSF assay provides quantitative measurement of total protein that is present in human urine and cerebral spinal fluid (CSF). Measurement is accomplished using a turbidimetric method.
Reagents for the COBAS Integra 400 plus analyzer are packaged in a cobas c pack with two bottles labeled with their instrument positioning, Reagent R1 in position B and Reagent SR in position C.
R1 contains Sodium Hydroxide: 677 mmol/L; EDTA-Na: 74 mmol/L
SR contains Benzethonium chloride: 32 mmol/L
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K Number
K013643Device Name
AUSAM TOTAL ALBUMIN ASSAY
Manufacturer
AUSAM BIOTECTHNOLOGIES INC
Date Cleared
2003-08-14
(647 days)
Product Code
JIQ
Regulation Number
862.1645Why did this record match?
Product Code :
JIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Total Intact Albumin Assay (also known as the AusAm Microalbumin Plus Urinary Assay) is intended for in vitro diagnostic use in the quantitation of intact albumin in human urine. Measurement of intact albumin with this assay aids in the identification of patients who may warrant further testing for kidney or intestinal disease.
Device Description
Not Found
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K Number
K991800Device Name
HEMOCHEK URINE COLLECTION KIT
Manufacturer
OSBORN GROUP, INC.
Date Cleared
1999-09-24
(121 days)
Product Code
JIQ, CGX, FMH
Regulation Number
862.1645Why did this record match?
Product Code :
JIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.
Device Description
The HemoChek Urine Collection Kit is a device used by a person under the supervision of a trained health care professional to obtain a urine specimen midstream or by dipping the absorbent pad in a cup of urine, contain the specimen, and preserve the specimen after collection and during mailing to the laboratory for testing of creatinine and microalbumin concentrations. The device consists of the following:
- A collector pad holder/handle with a collector pad and a protective cover over the pad, contained in a sealed "peel-apart" plastic envelope. The collector pad holder/ handle itself consists of two parts, a collector pad holder and a collector pad slider. The collector pad is held in the holder/handle by a pin in the slider that fits into a hole in the collector pad, and by the holder, which keeps the pad from falling off the pin. The slider has a round indicator port in it. A blue color appears in this indicator port when a sufficient amount of urine has been collected.
- A Specimen Tube with a screw-on lid, containing preservative fluid.
- A clear plastic sealed envelope that contains both of the above items.
- A Patient Identification Card which contains the patient's name, address, Social Security Number, Insurance information, the Doctor's name and a bar-coded label which is peeled off and attached to the Collection Tube after the sample has been taken.
- A set of instructions.
- A zip lock bag into which the Specimen Tube is placed after the sample has been taken.
- A mailer into which the zip lock bag is placed.
- A polyethylene mailing envelope which contains all of the above items and is used to mail the HemoChek Urine Collection Kit to the patient.
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K Number
K971458Device Name
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT
Manufacturer
DIAGNOSTIC SPECIALTIES
Date Cleared
1997-09-02
(133 days)
Product Code
JIQ
Regulation Number
862.1645Why did this record match?
Product Code :
JIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Microalbuminurea has been shown to predict the development of clinically significant nephropathy in diabetic patients. This Urinary Microalbumin Assay Kit is an in vitro immunoturbidimetric test for the quantitative determination of the native, immunoreactive albumin present in human urine.
Device Description
EnZIP IMMUNOTURBIDIMETRIC URINARY MICROALBUMIN KIT
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K Number
K965035Device Name
IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
Manufacturer
BECKMAN INSTRUMENTS, INC.
Date Cleared
1997-04-17
(121 days)
Product Code
JIQ
Regulation Number
862.1645Why did this record match?
Product Code :
JIQ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMMAGE Immunochemistry System Microalbumin (MA) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Urine Protein Calibrator, is intended for the quantitative determination of micro quantities of albumin in urine by rate nephelometry.
Device Description
The IMMAGE Immunochemistry System MA Reagent in conjunction with Beckman Urine Protein Calibrator, is intended for use in the quantitative determination of micro quantities of micro albumin in in human urine samples on Beckman's IMMAGE™ Immunochemistry System.
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