(98 days)
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No
The summary describes a laboratory assay (immunoradiometric assay) for measuring hormone levels, which is a standard biochemical test method and does not mention any AI or ML components.
No.
The device is a diagnostic test system used to measure PTH levels, which aids in diagnosing calcium metabolism disorders, rather than treating them.
Yes
The text states, "Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia...and hypocalcemia..." which indicates its use in diagnosing conditions.
No
The device description explicitly states it is an "Immunoradiometric Assay (Coated Tube Version)," which is a laboratory test involving physical components (coated tubes) and chemical reactions, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is "intended to measure the levels of parathyroid hormone in serum and plasma." This involves testing biological samples (serum and plasma) in vitro (outside the body).
- Diagnostic Purpose: The intended use also specifies that these measurements "are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This indicates the test is used to aid in the diagnosis of medical conditions.
- Device Description: The description "Total Intact PTH Immunoradiometric Assay (Coated Tube Version)" further confirms it's a laboratory test system designed to analyze biological samples.
These characteristics align directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) 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.
Product codes
CEW
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "U.S. Department of Health & Human Services (USA)" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Nordstrom OA/RA Manager Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, California 92071
OCT 1 8 2005
Re: K051888
Trade/Device Name: Total Intact PTH Immunoradiometric Assay (Coated Tube Version) Regulation Number: 21 CFR § 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW Dated: September 22, 2005 Received: September 28, 2005
Dear Mr. Nordstrom:
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 commerce prior 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. Benson
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
2
Indications for Use
6051888
510(k) Number (if known):
Device Name: Total Intact PTH IRMA (Coated Tube Version Assay) _______________________________________________________________________________________________________________
Indications For Use:
The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) 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.
Prescription Use XX (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)
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