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510(k) Data Aggregation
K Number
K031356Device Name
HEMAPROMPT GASTRIC
Manufacturer
Date Cleared
2003-09-24
(166 days)
Product Code
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
AERSCHER DIAGNOSTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HemaPrompt Gastric is a guaiac-based in-vitro method for the qualitative detection of occult blood in gastric aspirate or vomitus by medical professionals only. A separate segment of pH paper is provided on the slide for estimation of pH of the gastric juice.
It is used for the early detection of occult blood in such conditions as gastric trauma, gastric or duodenal ulceration, gastric cancer, esophageal varices, situations of exogenous or endogenous gastritis, leukemia, and hereditary telangiectasia. These conditions may be encountered in the emergency room, recovery room or intensive care.
Device Description
The HemaPrompt Gastric slide, used with a buffered developer and a buffered guaiac paper, is a guaiac based test for the detection of occult blood in gastric samples. The test is not affected by low pH, and is free from interferences by normal therapeutic concentrations of iron, ranitidine, and antacids. A separate area is provided to test for the pH of the specimen.
When a gastric specimen containing blood is applied to the HemaPrompt Gastric test paper, hemoglobin from the lysed blood cells in the sample comes in contact with the guaiac in the paper. The developer, a buffered solution of alcohol and hydrogen peroxide, which is applied with two drops to the guaiac on the slide, creates a peroxidase-like reaction in the presence of hemoglobin which in turn causes a blue coloration in the test paper. This test will turn blue in the presence of more than 100 mcg Hb/ ml gastric juice.
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K Number
K981661Device Name
HEMAPROMPT
Manufacturer
Date Cleared
1998-09-15
(132 days)
Product Code
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
AERSCHER DIAGNOSTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HemaPrompt is a guaiac-based in-vitro slide method for the qualitative detection of occult blood in feces by lay persons.
It is a useful aid in the diagnosis or early detection of a number of gastrointestinal disorders, and is recommended for use in monitoring for recurrences of previously treated bowel conditions, and in screening for colorectal cancer or for other sources of gastro-intestinal bleeding.
For Over-The-Counter Use
Device Description
HemaPrompt is presently approved and being used by health care professionals for the screening of stool for occult blood. It is a guaiac based system using a color change in the test slide to show the presence of a pathological amount of blood in the stool, which indicates the need for further investigation by medical personnel.
HemaPrompt for use at home is the same in configuration and chemical constitution as that currently used by professionals. HemaPrompt is much simpler and safer to use than similar home-use kits because the developing solution is individually contained in each slide thereby obviating the need to measure or handle a potentially hazardous solution. This design also obviates variations in user technique, and because of a "built - in" control monitor, proper function is obvious.
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K Number
K972763Device Name
HEMAPROMPT
Manufacturer
Date Cleared
1997-10-20
(88 days)
Product Code
Regulation Number
864.6550Why did this record match?
Applicant Name (Manufacturer) :
AERSCHER DIAGNOSTICS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
HemaPrompt is a gualac-based in-vilro slide method for the qualitative detection of occult blood in feces and gastric aspirate or vomitus by medical professionals only.
For fecal testing, it is a useful ald In the diagnosis of a number of gastrointestinal disorders, and is recommended for use in 1) routine physical examinations 2) routine hospital testing 3) screening for colorectal cancer or gastro-Intestinal bleeding from any other source.
For the testing of gastric contents it is used for the early detection of occult blood in conditions such as gastric trauma, gastric or duodenal ulceration, gastric cancer, esophageal varices, situations of likely exogenous or endogenous gastrills, leukemia, and hereditary telangiectasia. These conditions may be encountered in the emergency room, recovery room or intensive care.
Device Description
The HemaPrompt slide, used with a buffered developer, is a guaiac based test for the detection of occult blood in both gastric and fecal samples. The test is not affected by low pH. When used with gastric specimens, it is free from interferences by normal therapeutic concentrations of iron, ranitidine, cimetidine and antacids.
When a gastric or fecal specimen containing blood is applied to the HemaPrompt test paper, hemoglobin from the lysed blood cells in the sample comes in contact with the guaiac in the paper. The developer, a buffered solution of alcohol and hydrogen peroxide, is applied by pulling the tab on the slide and creates a guaiac / peroxidase-like reaction in the presence of hemoglobin which in turn causes a blue coloration in the test paper. This test will turn blue in the presence of more than 2 mg Hb/ G stool and more than 200 mcg Hb/ ml gastric juice
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