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510(k) Data Aggregation
K Number
K232892Device Name
Hp Detect Stool Antigen ELISA
Manufacturer
Biomerica, Inc.
Date Cleared
2023-12-15
(88 days)
Product Code
LYR
Regulation Number
866.3110Why did this record match?
Applicant Name (Manufacturer) :
Biomerica, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hp Detect™ Stool Antigen ELISA is an in vitro diagnostic qualitative enzyme immunoassay for the detection of Helicobacter pylori (H. pylori) antigens in human stool or feces. The Hp Detect™ Stool Antigen ELISA is intended to aid in the initial diagnosis and post-therapy diagnosis of H. pylori infection. Additionally, the test may be used to assess H. pylori infection status after treatment. Retesting at a minimum of 4 weeks after the completion of treatment may be done to assess H. pylori status. Test results should always be taken into consideration by the physician in conjunction with patient's clinical information (history and symptoms). For Prescription Use Only.
Device Description
The Hp Detect Stool Antigen ELISA is an enzyme immunoassay which detects the H. pylori antigen in human fecal samples. The Hp Detect Stool Antigen ELISA comes in a kit that contains materials to assay a total of 92 samples. The device consists of a 96-well clear flat bottom polystyrene high bind microplate coated with affinity purified rabbit anti-human H. pvlori polyclonal antibody. The device is provided with detection antibody which is a purified mouse monoclonal antibody specific for H. pylori antigen and has been conjugated to horseradish peroxidase (HRP). The device kit is also provided with sample diluent buffer, wash buffer, substrate solution, stop solution along with negative and positive controls. Negative control is a phosphate buffered protein solution and positive control is composed of purified H. pylori antigen (ATCC strain 43504) from cell lysate. Polyclonal anti-H. pylori captures antibodies that are immobilized on microwells. Patient samples prepared in sample diluent are added to the microwells and incubated for one hour at 37 ± 2℃. If the H. pvlori antigen is present in the sample, it will bind to the immobilized antibody on the plate. Following this incubation, the plate is washed thoroughly. A peroxidase conjugated anti-H. pylori monoclonal antibody is then added to the microwells and incubated for 30 minutes at 37 ± 2℃. If H. pylori antigen is bound to the microwells in the first step, the detection antibody would now bind in this step to form a sandwich complex. Following this incubation, a thorough wash step is performed to remove non-specific and non-binding materials. Substrate is then added and incubated for 10 minutes at 37±2℃ to generate a color in the presence of the enzyme complex. Stop solution is then added to end the reaction. The results are read spectrophotometrically at the following wavelengths: 1. Single Wavelength Measurement at 450 nm 2. Dual Wavelength Measurement 450/620 nm or 450/630 nm
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K Number
K003856Device Name
EZ-HCG URINE(PREGNANCY TEST)
Manufacturer
BIOMERICA, INC.
Date Cleared
2001-02-21
(70 days)
Product Code
JHI
Regulation Number
862.1155Why did this record match?
Applicant Name (Manufacturer) :
BIOMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982954Device Name
FREE T4 MICROWELL EIA, MODEL #7019
Manufacturer
BIOMERICA, INC.
Date Cleared
1998-09-24
(31 days)
Product Code
CEC
Regulation Number
862.1695Why did this record match?
Applicant Name (Manufacturer) :
BIOMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Free T4 EIA can be used as an in vitro Diagnostic test system for the quantitative determination of nonprotein-bound (Free) circulating Thyroxine (T4) in human serum. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases. It is not suitable for use in determination of thyroid status in neonatal patients.
Device Description
Not Found
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K Number
K962216Device Name
TSH (MICROWELL) ELISA
Manufacturer
BIOMERICA, INC.
Date Cleared
1996-09-19
(101 days)
Product Code
JLW
Regulation Number
862.1690Why did this record match?
Applicant Name (Manufacturer) :
BIOMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K960412Device Name
T-3 MICROWELL EIA MODEL 7013
Manufacturer
BIOMERICA, INC.
Date Cleared
1996-03-19
(50 days)
Product Code
CDP
Regulation Number
862.1710Why did this record match?
Applicant Name (Manufacturer) :
BIOMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Biomerica's T3 microwell EIA is Enzyme Immuno-assay test for the quantitative determination of Triodothyronine (T3 ) in human serum.
Device Description
Biomerica's T3 EIA is a sensitive solid phase enzyme immunoassay system for the quantitative determination of T3 in patient serum or plasma. Specific antibodies to T3 are immobilized on the inside surface of microwells of microtiter plate (96). A known volume of serum or plasma containing T3 and an enzyme labeled T3 conjugate are added to the antibody coated microwells. Both the T3 in the sample and the enzyme conjugated T3 compete for a limited number of binding sites available on the antibody. The unbound T3-enzyme conjugate is washed off from the microwells. A chromogen substrate mixture is added to the bound T3 enzyme conjugate to develop color. The intensity of the color developed is measure by the microtiter reader and is inversely proportional to the amount of T3 present in the patient's sample. The quantity of T3 present in the patient's sample (serum or plasma) is measured by extrapolating from the dose response curve (DRC) .
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