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510(k) Data Aggregation
K Number
K123805Device Name
E-Z CHEK BLOOD LEAK TEST STRIPS
Manufacturer
REPROCESSING PRODUCTS CORP.
Date Cleared
2013-03-20
(99 days)
Product Code
FJD
Regulation Number
876.5820Why did this record match?
Product Code :
FJD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reprocessing Products Corporation (RPC) E-Z Chek® Blood Leak Test Strips are designed to indicate the presence or absence of blood in dialysate during the hemodialysis procedure. The test strips will measure equal to 0 mg HGB/dL and 0.25 mg HGB/dL in dialysate.
The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.
Device Description
Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with blood in dialysate. The pad is attached to a plastic strip for handling.
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K Number
K042322Device Name
STERICHEK BLOOD LEAK REAGENT STRIPS
Manufacturer
HACH COMPANY
Date Cleared
2004-12-07
(103 days)
Product Code
FJD
Regulation Number
876.5820Why did this record match?
Product Code :
FJD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SteriChek® Blood Leak Reagent Strips provide a quick convenient means of testing for occult blood in dialysate.
SteriChek® Blood Leak Reagent Strips provide a quick convenient means of checking the presence of Blood in dialysate to assist in confirming an alarm by the blood leak monitor of the Hemodialysis machine.
Device Description
The device is made up of a 0.20 inch square yellow reagent pad that has been chemically treated to detect the presence of blood in the dialysate solution used in Hemodialysis. The pad is affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. To use the reagent strip, the reagent pad is immersed in the sample, removed immediately and allowed to react for 60 seconds. The reagent pad is then compared with the color blocks on the bottle label. The Negative color block is yellow with small blue-green speckles. If a reagent pad has a similar yellow color 60 seconds after reaction with dialysate, then the dialysate does not contain significant blood. The Positive color block is green. A reagent pad with color equal to or darker than the Positive color block indicates the presence of significant blood leak. The speckles on the color blocks represent the reaction image that might be left by intact red blood cells that might land on the reagent pad.
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K Number
K012115Device Name
SERIM BLOOD LEAK TEST STRIP-2
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
2001-11-30
(147 days)
Product Code
FJD
Regulation Number
876.5820Why did this record match?
Product Code :
FJD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Serim Blood Leak Test Strips – 2 provide a rapid and convenient means for testing dialysate for occult blood leaks that may occur during the conventional hemodialysis procedure or continuous renal replacement therapy procedures such as continuous arteriovenous hemodialysis or continuous venovenous hemodialysis.
Device Description
The SERIM Blood Leak Test Strips-2 consist of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.
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K Number
K990206Device Name
SERIM BLOOD LEAK TEST STRIP
Manufacturer
SERIM RESEARCH CORP.
Date Cleared
1999-04-21
(90 days)
Product Code
FJD
Regulation Number
876.5820Why did this record match?
Product Code :
FJD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SERIM Blood Leak Test Strips provide a rapid and convenient means for testing spent dialysate for blood in hemodialysis clinics. The presence of blood in dialysate indicates a leak in the dialysis membrane.
Device Description
The SERIM Blood Leak Test Strip consists of a 0.2 x 0.2 inch reagent pad attached to one end of a white 0.2 x 3.25 inch polystyrene handle. The reagent pad is immersed into a sample, removed immediately and allowed to react for 60 seconds. Then the reagent pad color is compared to two color blocks on the bottle label. One color block marked Negative is yellow with a few green speckles. If a reagent pad has a similar yellow color the dialysate does not contain significant blood. The second color block is green with small yellow speckles and is marked Positive. A reagent pad with green color equal to or darker than this color block indicates the presence of a significant blood leak.
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