WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014

K051810 · Scantibodies Laboratory, Inc. · CEW · Sep 9, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051810
• Device Name: WHOLE PTH (1-84) SPECIFIC IMMUNORADIOMETRIC ASSAY (IRMA) COATED TUBE KIT, MODEL 3KG014
• Applicant: Scantibodies Laboratory, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Sep 9, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma and serum. PTH measurements 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 Whole PTH Immunoradiometric (IRMA) Tube Assay is an in vitro diagnostic test system used to quantify parathyroid hormone levels in human plasma or serum samples. The device utilizes an immunoradiometric assay (IRMA) principle, where PTH in the patient sample is captured and labeled with radioactive markers to produce a signal proportional to the hormone concentration. The assay is performed in a laboratory setting by trained technicians. Healthcare providers use the resulting PTH concentration values to aid in the differential diagnosis of calcium metabolism disorders, specifically hypercalcemia and hypocalcemia. By providing accurate hormone quantification, the device assists clinicians in identifying the underlying cause of calcium imbalances, thereby guiding appropriate therapeutic interventions for patients.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoradiometric assay (IRMA) tube-based system. Measures parathyroid hormone in plasma and serum. In vitro diagnostic device. Class II, Product Code CEW.

Indications for Use

Indicated for the measurement of parathyroid hormone in human plasma and serum to assist in the 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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure. The logo is in black and white.

Public Health Service

SEP - 9 2005

Food and Drug Administratio 2098 Gaither Road Rockville MD 20850

Mr. Michael Nordstrom QA/RA Manager Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, California 92071

k051810 Re:

K051610
Trade/Device Name: Whole PTH Immunoradiometric (IRMA) Tube Assay Regulation Number: 21 CFR § 862.1545 Regulation Name: Parathyroid hormone test system Regulatory Class: II Product Code: CEW Dated: August 27, 2005 Received: August 31, 2005

Dear Mr. Nordstrom:

We have reviewed your Section 510(k) premarket notification of intent to market the device wf 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 encrobate) to regard and the Medical Device Amendments, or to continered prial to May 20, 1978, the oncordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). alle Cosment Act (71ct) that do not required to the general controls provisions of the Act. The r ou may, therefore, manel are act include requirements for annual registration, listing of general ochiles provinsitive, 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 may oc subject to such adultions vehicles in the segulations (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 i tease be activised that I Drivision that your device complies with other requirements of the Act that I Dri has intact and regulations administered by other Federal agencies. You must or any I cuthat statutes and regentlers, 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/industry/support/index.html.

Sincerely yours,

Carol C. Benam

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):

Device Name: Whole PTH Immunoradiometric (IRMA) Tube Assay

Indications For Use:

The Scantibodies Laboratory, Inc. Whole Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma and serum. PTH measurements 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 Y (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) 220-

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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