CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001

K031534 · Scantibodies Laboratory, Inc. · CEW · Jul 30, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031534
• Device Name: CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001
• Applicant: Scantibodies Laboratory, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Jul 30, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The Cyclase Activating PTH (CAP) IRMA Assay has been designed for the quantitative determination of Cyclase activating parathyroid hormone (PTH) without cross-reaction to PTH (7-84) fragment in serum and plasma samples. The 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.

Device Story

The Parathyroid Hormone (PTH) Immunoradiometric IRMA Assay is an in vitro diagnostic test used to quantify PTH levels in human serum or plasma samples. The device utilizes an immunoradiometric assay (IRMA) principle, where specific antibodies bind to the PTH analyte, allowing for detection and measurement. The assay is performed in a laboratory setting by trained technicians. Results are provided to clinicians to aid in the differential diagnosis of calcium metabolism disorders, specifically hypercalcemia and hypocalcemia. By providing accurate PTH concentration data, the device assists healthcare providers in identifying the underlying cause of abnormal calcium levels, thereby guiding appropriate clinical management and treatment strategies for patients with parathyroid-related conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoradiometric assay (IRMA) using polystyrene beads coated with goat anti-PTH (39-84) and 125I-labeled goat anti-PTH tracer. Quantitative measurement range 1.0–2300 pg/mL. Requires gamma counter for detection. Reagents provided in lyophilized form. Standardized via NCCLS C28-A guidelines.

Indications for Use

Indicated for quantitative determination of cyclase activating PTH in serum and plasma to aid differential diagnosis of hypercalcemia and hypocalcemia related to calcium metabolism disorders.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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 [phone] · Fax [phone]

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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

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Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and

510(k) K031534