(83 days)
The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
Not Found
The provided document is a 510(k) clearance letter from the FDA for the "Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay." This document primarily focuses on the regulatory clearance process and does not contain specific details about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert ground truth establishment, or similar scientific study details typically found in a clinical trial report or scientific publication.
Therefore, I cannot provide the requested information based on the given text. The letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it doesn't describe the studies that led to that determination in the detail you're asking for.
To answer your questions, I would need access to the actual 510(k) submission document or a detailed performance study report for the device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
JUL 26 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Nordstrom QA/RA Manager Scantibodies Laboratory, Inc. 9336 Abraham Way Santee CA 92071
Re: K051150
K051150
Trade/Device Name: Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: April 29, 2005 Received: May 4, 2005
Dear Mr. Nordstrom:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enerobars) to regars actment date of the Medical Device Amendments, or to conninered pror to this 20, 1978, the occordance with the provisions of the Federal Food, Drug, devices that have over require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dicrerors, manel 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 r lease oe arrised that I Dr over device complies with other requirements of the Act that I Dr. Has Intact and regulations administered by other Federal agencies. You must or any I ederal statutes and regaraments, including, but not limited to: registration and listing (21 compry with and the marts 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) rms letter will anon you w oogin mading of substantial equivalence of your device to a legally promative notification - 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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Indications for Use
510(k) Number (if known): _K051150
Device Name: Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay
Indications For Use:
.
The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.
Prescription Use צ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device
Evaluation and Safety
Page 1 of 1510(k) K051150
§ 862.1545 Parathyroid hormone test system.
(a)
Identification. A parathyroid hormone test system is a device intended to measure the levels of parathyroid hormone in serum and plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia (abnormally high levels of calcium in the blood) and hypocalcemia (abnormally low levels of calcium in the blood) resulting from disorders of calcium metabolism.(b)
Classification. Class II.