(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.
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JUL 1 9 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Eve Schwartz VP of Operations Salimetrics, LLC 101 Innovation Boulevard Suite 302 State College, PA 16803
$
K051012 Re:
Trade/Device Name: Salimetrics Progesterone Standard Calibrator and Control Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJY Dated: April 13, 2005 Received: April 25, 2005
Dear Ms. Schwartz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Carol C. Benem
Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Salimetrics, LLC Progesterone Calibrator
FDA Establishment Registration Number:9045886
Indications for Use
510 (k) Number: K051012
ട്രാ (1) Name: 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 Progesterone Nigh our a saliva-like matrix with a non-mercury preservative.
Indications for Use:
The salivary progesterone calibrator is a device intended for medical purposes to use in the The salivaly progesterone callibring and to establish points of reference that are used to Salimothes comp in the measurement of free progesterone in saliva.
The salivary progesterone controls are devices intended for use in monitoring the performance of the salivary immnuoassay of free progesterone in saliva.
Over-the-Counter Use (OTC): __________________________________________________________________________________________________________________________________________________ Prescription Use: __ X ____ and/or
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE I F NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K051012
§ 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.