IMMULITE TURBO INTACT PTH, MODEL LSKPTZ

K992105 · Diagnostic Products Corp. · CEW · Jul 6, 1999 · Clinical Chemistry

Device Facts

• Record ID: K992105
• Device Name: IMMULITE TURBO INTACT PTH, MODEL LSKPTZ
• Applicant: Diagnostic Products Corp.
• Product Code: CEW · Clinical Chemistry
• Decision Date: Jul 6, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1545
• Device Class: Class 2

Intended Use

IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

Device Story

IMMULITE Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay. It processes EDTA plasma or serum samples using the IMMULITE Automated Analyzer. The device measures intact parathyroid hormone (PTH) levels. It is used in clinical laboratory settings by trained personnel. The output is a quantitative measurement of PTH, which assists healthcare providers in the differential diagnosis of hypercalcemia and hypocalcemia, facilitating appropriate patient management.

Clinical Evidence

No clinical data provided in the document; summary relies on safety and effectiveness data submitted for 510(k) clearance.

Technological Characteristics

Solid-phase, two-site chemiluminescent enzyme immunometric assay. Designed for use with the IMMULITE Automated Analyzer. In vitro diagnostic reagent system.

Indications for Use

Indicated for the quantitative measurement of intact parathyroid hormone (PTH) in EDTA plasma or serum to aid in the differential diagnosis of hypercalcemia and hypocalcemia in patients.

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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K 992105

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## 510(k) Summary Safety and Effectiveness

"

This summary of safety and effectiveness information has been prepared in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

Name: Address:

Telephone Number: Facsimile Number:

Contact Person:

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Edward M. Levine, Ph.D. Director of Clinical Affairs

IMMULITE® Turbo Intact PTH

[phone]

[phone]

June 21, 1999

LSKPTZ (50 tests)

EDTA plasma or serum.

5700 West 96th Street

Date of Preparation:

Device Name: Trade:

Catalog Number:

Common:

Classification:

Manufacturer:

Sole U.S. Importer:

Diagnostic Products Corporation 5700 West 96th Street Los Angeles, California 90045-5597

Los Angeles, California 90045-5597

Diagnostic Products Corporation

Establishment Registration Number:

Description of Device:

DPC's Registration Number is 2017183

Class II device, 75-CEW (21CFR 862.1545)

IMMULITE® Turbo Intact PTH is a clinical device for use with the IMMULITE® Automated Immunoassay Analyzer,

Reagent system for the determination of intact PTH in

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## Intended Use of the Device:

IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or It is intended strictly for in vitro use as an aid in the differential diagnosis of serum. hypercalcemia and hypocalcemia.

## Conclusion:

The data presented in this summary of safety and effectiveness is the data that the Food and Drug Administration used in granting DPC substantial equivalence for IMMULITE® Turbo Intact PTH.

Edward A. Levine, Ph.D.

Edward M. Levine, Ph.D. Director of Clinical Affairs

6/21/99
**Date**

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL -6 1999

Edward M. Levine, Ph.D. Director of Clinical Affairs Diagnostics Products Corporation 5700 West 96th Street Los Angeles. California 90045-5597

Re: K992105

> Trade Name: IMMULITE® Turbo Intact PTH Regulatory Class: II Product Code: CEW Dated: June 21, 1999 Received: June 22, 1999

Dear Dr. Levine:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the @ffice of Compliance at ** [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Toutman

Steven I. Gutman, M.D. M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 449105 Device Name: IMMULITE® Turbo Intact PTH

Indications For Use:

IMMULITE® Turbo Intact PTH is a solid-phase, two-site chemiluminescent enzyme immunometric assay for use with the IMMULITE Automated Analyzer and designed for the quantitative measurement of intact parathyroid hormone (parathyrin, PTH) in EDTA plasma or serum. It is intended strictly for in vitro use as an aid in the differential diagnosis of hypercalcemia and hypocalcemia.

Coofer

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K992105

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

i

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-

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