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The document is a 510(k) summary for the ARCHITECT Cortisol assay and its calibrators, submitted by Seradyn, Inc. It outlines the device's intended use for the quantitative determination of cortisol in human serum, plasma, or urine to aid in diagnosing adrenal disorders. The summary includes details on device classification, technological characteristics, clinical testing results, and comparisons with a legally marketed predicate device (AXSYM Cortisol). The document concludes that the ARCHITECT Cortisol assay is substantially equivalent to the Abbott AxSYM Cortisol assay.

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What is the Food and Drug safety Act?

The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or adulterated food and drugs in interstate commerce and laid a foundation for the nations first consumer protection agency, the Food and Drug Administration (FDA).

What is the food drug and consumer Act?

The FDCA authorizes the FDA with the following tasks, among many others: Mandate drug manufacturers to submit evidence of new drugs safety and effectiveness before marketing and distribution to the general public. Issue and enforce quality standards for food, drugs, medical devices, and cosmetics.

Who is the administrator of the FDA?

Leadership Role. Commissioner of Food and Drugs - Food and Drug Administration. Robert M. Califf, M.D., is Commissioner of Food and Drugs.

What is the Sherley Amendment?

1912 Congress enacts the Sherley Amendment to overcome the ruling in U.S. v. Johnson. It prohibits labeling medicines with false therapeutic claims intended to defraud the purchaser, a standard difficult to prove.

What is the FSMA summary?

Under FSMA, FDA was given a legislative mandate to require comprehensive, science-based preventive controls across the food supply, including mandatory preventive controls for food facilities. Food facilities are required to implement a written preventive controls plan.

What was the FDA called before?

The Bureau of Chemistrys name changed to the Food, Drug, and Insecticide Administration in July 1927, when the non-regulatory research functions of the bureau were transferred elsewhere in the department. In July 1930 the name was shortened to the present version.

What is the purpose of the FDA?

The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nations food supply, cosmetics, and products that emit radiation.

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