TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY

K972666 · Hybritech, Inc. · CIN · Sep 11, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972666
• Device Name: TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY
• Applicant: Hybritech, Inc.
• Product Code: CIN · Clinical Chemistry
• Decision Date: Sep 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1050
• Device Class: Class 2

Intended Use

The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

Device Story

Tandem-MP Ostase is an in vitro solid-phase immunoenzymetric assay for quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum; used as aid in management of postmenopausal osteoporosis and Paget's disease. Input: human serum samples. Process: reaction in microwell with biotinylated capture antibody; binding to streptavidin-coated wells; incubation with enzyme substrate; colorimetric measurement of absorbance at 405 nm via microplate reader. Output: sALP concentration calculated via concurrent testing of calibrators. Used in clinical laboratory settings by trained personnel. Results assist healthcare providers in assessing osteoblastic activity to inform clinical management decisions.

Clinical Evidence

No clinical data provided; substantial equivalence established via technological comparison to predicate.

Technological Characteristics

Solid-phase immunoenzymetric assay; biotinylated capture antibody; streptavidin-coated microwells; enzyme substrate; colorimetric detection at 405 nm; microplate reader required.

Indications for Use

Indicated for quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum to aid in management of postmenopausal osteoporosis and Paget's disease.

Regulatory Classification

Identification

An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

Predicate Devices

• Tandem-R Ostase Immunoradiometric Assay (K961573)

Submission Summary (Full Text)

{0}------------------------------------------------

## SUMMARY OF SAFETY AND EFFECT SECTION X: THE TANDEM-MP OSTASE ASSAY

Tandem-MP Ostase is an in vitro device for the quantitative measurement of skeletal alkaline phosphatase (sALP) in human serum. The assay is a solid-phase, immunoenzymetric assay. Serum samples containing sALP are reacted in a microwell with the biotinylated capture antibody. Following binding of the biotinylated antibody/antigen complex to the streptavidin coated wells, the microwells are washed and incubated with an enzyme substrate. The captured sALP enzyme turns over the substrate and the amount of sALP bound to the microwell is determined colorimetrically by measuring the absorbance of the quenched reaction at 405 nm in a microplate reader. The calculation of the sALP concentration in the sample is based on concurrent testing of the Ostase Calibrators and Zero/Diluent.

{1}------------------------------------------------

This premarket notification has demonstrated that the Tandem-MP Ostase Immunoenzymetric Assay for the quantitative measurement of skeletal alkaline phosphatase to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease is substantially equivalent to the Tandem-R Ostase Immunoradiometric Assay that was cleared by FDA in a previous submission (#K961573).

The Safe Medical Devices Act of 1990 states that a device is substantially equivalent to its predicate if they have the same technological characteristics and the same intended use. The Tandem-MP Ostase device that is the subject of this submission has technological characteristics that are the same as those of the predicate device.

{2}------------------------------------------------

The intended use of Tandem-MP Ostase remains unchanged from the predicate with regard to the analyte being measured (skeletal alkaline phosphatase) and the specimen matrix (human serum). Therefore, it has been demonstrated in this submission that the Tandem-MP Ostase assay is substantially equivalent to the predicate device and is safe and effective as an aid in the management of postmenopausal osteoporosis and Paget's disease.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other to create a sense of depth and unity.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEP 1 1 1997

Gregory P. Payne, RAC Principal Regulatory Specialist Hybritech, Inc. 8958 Terman Court 92121 San Diego, California

K972666 Re : Tandem-MP Ostase™ Immunoenzymetric Assay Requlatory Class: II Product Code: CIN Dated: July 16, 1997 July 16, 1997 Received:

Dear Mr. Payne:

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 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 The general controls provisions of the Act 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. ਸੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) 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 requlation may result in regulatory In addition, FDA may publish further announcements action. 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 requlations.

{4}------------------------------------------------

Page 2

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity (CDIA-66), Child device may require does, you should contact Categorization: - 10 accemention (CDC) at [phone].

This letter will allow you to begin marketing your device as Inis lector will and the premarket notification. The FDA described in your sister privalence of your device to a legally Finding or subbeancear equire in a classification for your marketed predicate device rour 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 Office 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/dsmamain.html".

sincerely yours,
Steven Gutman

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

{5}------------------------------------------------

## SECTION 11: INDICATION FOR USE

The Tandem-MP Ostase Immunoenzymetric Assay is an in vitro device indicated for the quantitative measurement of skeletal alkaline phosphatase (sALP), an indicator of osteoblastic activity, in human serum. This device is intended to be used as an aid in the management of postmenopausal osteoporosis and Paget's disease.

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 4972666

\/
Prescription Use

Tandem-MP Ostase 510(k): July 16, 1997

18