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The salivary progesterone calibrator is a device intended for medical purposes to use in the calibration and to establish points of reference that are used to calibrate the Salimetrics immunoassay in the measurement of free progesterone in saliva.

The salivary progesterone controls are devices intended for use in monitoring the performance of the salivary immunoassay of free progesterone in saliva.

Progesterone Standard Calibrator, one (1)mL of progesterone in a saliva-like matrix at a concentration of 2430 pg/mL with a non-mercury preservative.

Progesterone High Control (1000 pg/mL) and Progesterone Low Control (50.6 pg/mL) in a saliva-like matrix with a non-mercury preservative.

This document is a 510(k) clearance letter from the FDA for a device called "Salimetrics Progesterone Standard Calibrator and Control." It appears to be a regulatory document and does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report or a detailed submission document supporting the 510(k).

Therefore, I cannot extract the requested information to fill in the table and answer the study-related questions.

Here's why the input does not contain the requested information:

• Nature of the Document: This is an FDA clearance letter, which states that the device is "substantially equivalent" to a legally marketed predicate device. It signifies regulatory approval but does not typically include the detailed performance data and study design details from the original submission.
• Missing Information: The document focuses on the regulatory aspects (device name, regulation number, product code, substantial equivalence finding, and general controls) rather than a deep dive into the performance studies used to achieve that equivalence.
• "Indications for Use" Page: The "Indications for Use" section describes what the device is for (calibrator and controls for measuring progesterone in saliva) but does not provide performance metrics or study details.

To answer your questions, I would need access to the actual 510(k) submission document, which would contain the detailed studies and performance data.

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Salimetrics HS-Cortisol kit is a competitive immunoassay specifically designed for the quantitative in vitro diagnostic measurement of salivary cortisol. This kit may be used to measure adrenal cortical function and as a screen for Cushing's and Addison's disease. Saliva cortisol accurately reflects the amount of serum cortisol in the circulation. This kit is not intended for use with serum or plasma samples.

Test Principle- A microtitre plate is coated with rabbit antibodies to cortisol. Cortisol in standards and unknowns compete with cortisol linked to horseradish peroxidase for the antibody binding sites. After incubation, unbound components are washed away. Bound cortisol peroxidase is measured by the reaction of the peroxidase enzyme on the substrate tetramethylbenzidine (TMB). This reaction produces a blue color. A vellow color is formed after stopping the reaction with sulfuric acid. Optical density is read on a standard plate reader at 450 nm. The amount of cortisol peroxidase detected is inversely proportional to the amount of cortisol present. The optical density readings of the calibrators are used to form a standard curve to which the optical densities of the controls and samples are compared.

Kit Description- The kit consists of an antibody coated 96 well plate, six calibrators at a concentration of 1.800, 0.600, 0.200, 0.067. 0.022, and 0.007 µg/dL of NIST(National Institute of Standards and Technology) cortisol, two controls representing a high (1.00 ug/dL) and low (0.100 ug/dL) level of salivary cortisol, the enzyme conjugate (1600X concentrate), assay diluent containing a pH indicator, wash buffer(10X concentrate), tetramethylbenzidine substrate solution, stop solution, and kit insert.

Here's a breakdown of the acceptance criteria and study information for the Salimetrics HS Salivary Cortisol Enzyme Immunoassay Kit:

Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are framed in comparison to a predicate device (Diagnostic Systems Laboratory Active Cortisol EIA, K850141), focusing on quantitative performance characteristics.

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