(75 days)
Not Found
None
No
The summary describes a standard immunoradiometric assay for measuring parathyroid hormone levels and does not mention any AI or ML components.
No.
The device is a diagnostic test system used to measure parathyroid hormone levels, which aids in diagnosis rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section states that measurements from this device "are used in the differential diagnosis of hypercalcemia...and hypocalcemia."
No
The device description explicitly states it is an "Immunoradiometric IRMA Assay," which is a laboratory test method involving physical reagents and equipment, not solely software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is "intended to measure the levels of parathyroid hormone in serum and plasma." Serum and plasma are biological specimens taken from the body, but the testing is performed outside the body (in vitro).
- Purpose of Measurement: The measurements are used "in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism." This indicates the test is used for medical purposes to aid in diagnosis.
- Device Description: The description "Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay" further confirms that this is a laboratory test performed on biological samples.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly fits that description.
N/A
Intended Use / Indications for Use
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.
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
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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
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Food and Drug Administration 2098 Gaither Fload Rockville MD 20850
JUL 3 0 2003
Mr. Richard Lenart Ouality Control & Assurance Manager Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071
Re: K031534
Trade/Device Name: Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay Regulation Number: 21 CFR 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: Class II Product Code: CEW Dated: May 09, 2003 Received: May 16, 2003
Dear Mr. Lenart:
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 (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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6192589366
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ODIES Laboratory, Inc.
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The Power of An to Select and Detect
9336 Abraham Way · Santee, CA 92071-2862 USA · Phone (619) 258-9300 · Fax (619) 258-9366
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Statement of Indications for Use
510(k) Number (if known): K031534
Device Name: Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay
Indications For Use:
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.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X
Jean Copy
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and
510(k) K031534