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510(k) Data Aggregation
K Number
K133303Device Name
PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device
Manufacturer
Date Cleared
2014-11-19
(390 days)
Regulation Number
862.1675Why did this record match?
Applicant Name (Manufacturer) :
BIO-ANALYSIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Pantex Salivary Direct Testosterone EIA Kit is an Enzyme Immunoassay (EIA) for the quantitative measurement of testosterone in human saliva collected with the Pantex Sample Collection Device. The measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, impotence in males hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries and adreno-genital syndromes.
Device Description
The Pantex Salivary Direct Testosterone EIA kit, Cat # 635 is based on the competition principal and microplate separation. Testosterone calibrators of known concentration, unknown amounts of testosterone in saliva samples and a fixed amount of testosterone (analog) conjugated to horse radish peroxidase (Testosterone-HRP) compete for binding sites with a rabbit monoclonal antiserum bound to GARGG (goat anti-rabbit gamma globulin) coated wells of a microplate. After incubation, unbound components are washed away, enzyme substrate solution is added and a blue color formed. This reaction is stopped with an acid solution to produce a yellow color. The optical density is then read at 450 nm. The amount of Testosterone-HRP detected is inversely proportional to the amount of testosterone in a sample.
The Pantex collection device is a 10 mL, non-sterile, plain polypropylene tube with a screw cap. It is provided as 50 units per package. The expiration date of the Pantex Sample Collection Device is 48 months from the day of manufacture.
The kit consists of a 96 well GARGG (goat anti-rabbit gamma globulin) coated microplate (12x8 breakable strip wells), one concentrated stock testosterone calibrator (62,500 pg/ml), one stock testosterone control (40,000 pg/ml), both traceable to the USP, Anti-Testosterone (rabbit monoclonal), 20X concentrated testosterone-peroxidase (analog), substrate solution, stop reaction solution and 10X concentrated wash solution.
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K Number
K102841Device Name
PANTEX AM/PM SALIVARY CORTISOL ENZYME IMMUNOASSAY
Manufacturer
Date Cleared
2012-05-08
(587 days)
Product Code
Regulation Number
862.1205Why did this record match?
Applicant Name (Manufacturer) :
BIO-ANALYSIS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For the in-vitro diagnostic quantitative determination of free and protein bound salivary cortisol in human saliva as an aid in the assessment of Cushing Syndrome and Addison's Disease. Measurements of cortisol in saliva are used in the diagnosis and treatment of disorders of the adrenal gland.
Device Description
The kit consists of a 96 well GARGG (Goat Anti-Rabbit Gamma Globulin) coated microplate (12x8 breakable strip wells), seven ready-to-use calibrators (range 0.1-30 ng/ml) of gravimetrically prepared cortisol from a commercial source (Steraloids) and compared and traced to NIST cortisol, low and high controls, anti-Cortisol (rabbit), 10X concentrated Cortisol (analog)-peroxidase, substrate solution, stop reaction solution and 10X concentrated wash solution.
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