MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT

K060348 · Scantibodies Laboratory, Inc. · CEW · Feb 27, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060348
• Device Name: MODIFICATION TO: TOTAL INTACT PTH IMMUNOCHEMILUMINOMETRIC (ICMA) ASSAY KIT
• Applicant: Scantibodies Laboratory, Inc.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Feb 27, 2006
• Decision: SESE
• Submission Type: Special
• 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 a crother incone 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. It measures parathyroid hormone levels in human plasma samples. The device utilizes an immuno-chemiluminometric assay principle to quantify PTH concentrations. It is intended for use by clinical laboratory professionals to aid in the differential diagnosis of calcium metabolism disorders, specifically hypercalcemia and hypocalcemia. The output provides quantitative PTH values, which clinicians use to evaluate parathyroid function and manage patient calcium homeostasis.

Clinical Evidence

Bench testing only. Data re-calibrated following adjustment factors applied to calibrators; verification and validation activities performed per design controls to ensure performance characteristics meet acceptance criteria.

Technological Characteristics

ImmunoChemiluminoMetric (ICMA) assay; recalibrated calibrators; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the quantitative determination of intact parathyroid hormone (PTH) in human serum or plasma.

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

Public Health Service

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FEB 2 7 2006

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Michael Nordstrom Director, Quality Assurance, Regulatory Affairs Scantibodies Laboratory, Inc. 9336 Abraham Way Santee, CA 92071

k060348 Re:

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: February 7, 2006 Received: February 10, 2006

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 [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,

Alberto G. A.

Alberto Gutierrez, Ph.D. 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):

K060348

Device Name: Total Intact PTH ImmunoChemiluminoMetric (ICMA) Assay

Indications For Use:

The Scantibodies Laboratory, Inc. Total Intact Parathyroid Hormone (PTH) test system is a device intended to measure parathyroid hormone in plasma. Measurements of a crother incone 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)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benson

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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