Search Results
Found 2 results
510(k) Data Aggregation
K Number
K954996Device Name
TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
Manufacturer
TREND SCIENTIFIC, INC.
Date Cleared
1996-08-08
(281 days)
Product Code
KHW
Regulation Number
866.3220Why did this record match?
Applicant Name (Manufacturer) :
TREND SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the device is for the qualitative and/ or quantitative determination of serum IgG antibodies to Entamoeba histolytica using an Enzyme-Linked Immunosorbent Assay (ELISA) technique.
Device Description
The device is an Enzyme Linked Immunosorbent Assay (ELISA). The antigen capture takes place in microwells. During the first incubation, antibodies in the patient's serum binds to antigen attached to the test wells. After washing the excess antibodies away, an enzyme complex binds to the antigen-antibody complex. After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex and peroxide. The stop solution ends the reaction and turns the The blue color to yellow. results read may be be spectrophotometrically with a microplate reader or visually.
Ask a Question
K Number
K955755Device Name
TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
Manufacturer
TREND SCIENTIFIC, INC.
Date Cleared
1996-07-11
(204 days)
Product Code
MHJ
Regulation Number
866.3220Why did this record match?
Applicant Name (Manufacturer) :
TREND SCIENTIFIC, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the device is for the qualitative determination Cryptosporidium antigen in feces. The ELISA test kit is of indicated for use with fecal specimens from patient's with diarrhea aid in the detection of Cryptosporidium gastrointestinal to infection.
Device Description
The device is an antigen capture enzyme linked immunosorbent assay (ELISA) for use with stools/ fecal material. The antigen capture takes place in microplate wells. During the first incubation, Cryptosporidium antigens present in the stool supernatant are captured by antibodies attached to the test wells. The second incubation adds an additional anti-Cryptosporidium antibody that "sandwiches" the antigen. The next incubation identifies the antibody/ antigen complex and amplifies the signal by the addition of an anti-immunoglobulin antibody conjugated to horse radish peroxidase (HRP). After washings that remove unbound enzyme, a substrate is added which develops a blue color in the presence of the enzyme complex. The stop solution ends the reaction and turns the blue color to yellow. The results may be read spectrophotometrically with a microplate reader or visually.
Ask a Question
Page 1 of 1