(89 days)
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.
§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.