PROLACTIN (PRL) HORMONE MICROPLATE ELISA

K971921 · Monobind · CFT · Jun 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971921
• Device Name: PROLACTIN (PRL) HORMONE MICROPLATE ELISA
• Applicant: Monobind
• Product Code: CFT · Clinical Chemistry
• Decision Date: Jun 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1625
• Device Class: Class 1

Intended Use

The Quantitative Determination of Prolactin Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or the hypothalamus portion of the brain.

Device Story

Prolactin (PRL) ELISA is a microplate-based enzyme immunoassay (IEMA) for human serum. Input: patient serum sample. Principle: two-site sandwich immunoassay using monoclonal biotinylated anti-PRL antibody and enzyme-labeled anti-PRL antibody. Complex forms in solution and deposits onto streptavidin-coated wells. After incubation and separation (decantation/aspiration), enzyme activity is measured, which is directly proportional to native PRL concentration. A dose-response curve is generated using known serum references to determine unknown concentrations. Used in clinical laboratories to assist physicians in diagnosing and treating pituitary or hypothalamic disorders.

Clinical Evidence

Clinical comparison performed using 86 specimens from normal (including pregnancy) and disease state populations. Mean values: 17.3 ng/ml (reference ICMA) vs. 19.0 ng/ml (subject IEMA). Linear regression: y = 1.01(x) + 1.63; correlation coefficient (r) = 0.973. Recovery data: 102.7% average recovery of exogenous PRL. Linearity studies: 96.7% average recovery upon dilution.

Technological Characteristics

Microplate enzyme immunoassay (IEMA). Components: streptavidin-coated polystyrene wells, monoclonal biotinylated anti-PRL antibody, enzyme-labeled anti-PRL antibody. Detection principle: enzyme activity proportional to antigen concentration. Standardized against international reference material.

Indications for Use

Indicated for the quantitative determination of prolactin (PRL) in human serum to aid in the diagnosis and treatment of disorders of the anterior pituitary gland or hypothalamus. Intended for use in clinical laboratory settings.

Regulatory Classification

Identification

A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

Predicate Devices

• Ciba Corning ACS 180 chemiluminescence (ICMA) test

Submission Summary (Full Text)

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KA71921

JUN 2 4 1997

Image /page/0/Picture/2 description: The image shows a logo for MONOBIND, INC. The logo consists of a stylized, interconnected set of shapes that resemble the letters 'M' and 'B'. Below the logo, the text "MONOBIND, INC." is printed in a simple, sans-serif font.

May. 21, 97

510(k) Summary

Dear Sir:

Monobind Inc., registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (IEMA) kit for the determination of prolactin (PRL) in human serum.

The proprietary name is Prolactin (PRL) ELISA and the usual name is PRL IEMA. This device classification name is - prolactin test system - product code CFT (per 21 CRF section 862.1625).

This device is substantially equivalent to the Ciba Corning ACS 180 chemiluminescence (ICMA) test, which predicates the new device.

The contact individual for this submission Is Dr. Frederick R. Jerome.

The Monobind ELISA method is based on two-site immunoassay (sandwich) technology utilizing the streptavidin-blotin reaction to effect separation. Upon mixing monoclonal blotinylated anti-PRL antibody, the enzyme-labeled anti-PRL antibody and a serum containing the native antigen (PRL), reaction results between the native antigen (PRL) and the antibodies, without competition or steric hindrance, to form a soluble sandwich complex. Simultaneously, the complex is deposited to the well through the high affinity reaction of streptavidin and biotinylated antibody. After incubation is complete, decantation or aspiration separates the bound fraction. The enzyme activity on the well is directly proportional to the native antigen (PRL) concentration. By utilizing several different serum references of known antigen values, a dose response curve can be generated from which the antigen concentration of an unknown can be ascertained.

The intended use of the device: The quantitative determination of prolactin (PRL) concentration in human serum by a microplate enzymeimmunoassay.

The technological characteristics of the new device compared to the predicate device are very similar. This includes the use of two-site immunoassay (sandwich) technology using monoclonal and polyclonal antibodies, and human serum prepared callbrators (standardized against the same international reference material). The main difference resides in the use of an enzyme tracer compared to chemiluminescence as well as magnetic particles versus streptavidin coated polystyrene wells.

Substantlal equivalency was based on clinical comparison (linear regression), using 86 specimens from normal (including pregnancy) and disease states' populations. The mean values for reference method (ICMA) and this method (microplate IEMA) are 17.3 ng/ml and 19.0 ng/ml respectively. The equation to a straight line [y= 1.01 (x) +1.63 ] and correlation coefficient (0.973) indicates good method agreement.

In addition recovery data demonstrated an average recovery of 102.7% when exogenous added prolactin was introduced into human serum specimens. Similarly, linearity studies showed an average 96.7% when specimens were diluted and compared to the dose response curve.

729 West 16" Street , Costa Mesa , CA (USA) 92627 Phone: [phone] FAX: [phone]

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JUN 2 4 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Dr. Frederick R. Jerome Monobind, Inc. 729 West 16th Street Costa Mesa, California 92627

Re: K971921 Prolactin (PRL) Hormone Microplate ELISA Regulatory Class: I Product Code: CFT Dated: May 22, 1997 May 23, 1997 Received:

Dear Dr. Jerome:

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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FPA) 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 Reqister. 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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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 lefter 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 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 qeneral 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 Litman

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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## Indications for Use Statement

510(k) Number (if known): K971921

Device Name: Prolactin (Prl) Hormone ELISA

The Quantitative Determination of Prolactin Hormone Concentration in Human Serum by a Microplate Immunoenzymometric assay. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or the hypothalamus portion of the brain.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

vision Sign-Off) Division of Clinical Laboratory S10(k) Number

Prescription Use

OR

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Folmat 1-2-96)