TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

K051150 · Scantibodies Laboratory, Inc. · CEW · Jul 26, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051150
• Device Name: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
• Applicant: Scantibodies Laboratory, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Jul 26, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended 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.

Device Story

The Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay is an in vitro diagnostic test system used to measure parathyroid hormone levels in human plasma samples. The device utilizes an immuno-chemiluminometric assay principle to quantify PTH concentrations. It is intended for use in clinical laboratory settings by trained laboratory personnel. The output, provided as a quantitative measurement of PTH, assists clinicians in the differential diagnosis of hypercalcemia and hypocalcemia. By identifying abnormal PTH levels, the assay aids in the clinical assessment of calcium metabolism disorders, facilitating appropriate patient management and treatment decisions.

Clinical Evidence

No clinical data provided; the submission relies on bench testing and substantial equivalence to legally marketed devices.

Technological Characteristics

Immunochemiluminometric assay (ICMA). Components: microtiter plate coated with anti-PTH (39-84) antibody, luminol-labeled anti-PTH (1-34) antibody, standards, controls, and triggering reagents. Requires microplate luminometer with dual injectors (100μL capacity). Analytical range up to 20,000 pg/mL. Standards calibrated against lyophilized primary standards. Complies with NCCLS guidelines EP6-A and C28-A.

Indications for Use

Indicated for the measurement of parathyroid hormone in plasma 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 features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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 [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. 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:

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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)

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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)
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Office of In Vitro Diagnostic Device
Evaluation and Safety
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