FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) by MONOBIND

The quantitative determination of follicle stimulating hormone (FSH) concentration in human serum and plasma by a microplate enzymeimmunoassay.Measurements of follicle-stimulating hormone are used in the diagnosis of pituitary gland and gonadotropin disorders.

Device Description

Monobind Inc., registration number 2020726, plans to introduce Into commercial distribution an enzymeimmunoassay (ELISA) kit for the determination of folliclestimulating hormone (FSH) in human serum and plasma.

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-FSH antibody, the enzyme-labeled anti-FSH antibody and a serum containing the native antigen (FSH), reaction results between the native antigen (FSH) 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 (FSH) 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.

AI/ML Overview

The provided document describes the Monobind Inc. Follicle-stimulating hormone (FSH) ELISA kit and its submission for 510(k) clearance. The focus of the acceptance criteria and study is on demonstrating substantial equivalence to a predicate device.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance and Outcome
Substantial Equivalence (Clinical Comparison)	Correlation Coefficient: The new device's results should have a strong correlation with the predicate device's results. This implies a high R-value (typically close to 1). Linear Regression: The relationship between the new device and the predicate device should be linear, allowing for predictable conversion or direct comparison, expressed as `y = mx + b`. Mean Values: The mean values of the new device should be comparable to the predicate device, indicating a similar central tendency in measurements.	Correlation Coefficient: 0.994, indicating very good method agreement. Linear Regression Equation: y = 0.93(x) - 1.5, showing a strong linear relationship. Mean Values: Predicate device (ICMA) mean = 21.0 mIU/ml; New device (ELISA) mean = 18.0 mIU/ml.
Analytical Recovery	Average Recovery Rate: When exogenous FSH is added to human serum specimens, the device should accurately recover the added amount, reflecting minimal interference or loss.	Average recovery of 99.9% when exogenous added FSH was introduced into human serum specimens.
Linearity (Dilution Studies)	Average Linearity: When specimens with varying FSH concentrations are diluted and compared to the dose response curve, the device should maintain accurate and proportional readings, demonstrating linearity across its measurement range.	Average linearity of 93.8% when specimens were diluted and compared to the dose response curve.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a clinical comparison study (sometimes referred to as a method comparison study) specifically designed to demonstrate substantial equivalence to the predicate device, the Ciba Corning ACS 180 chemiluminescence (ICMA) test.

2. Sample Size and Data Provenance:

Sample Size for Test Set: 128 specimens.
Data Provenance: The document does not explicitly state the country of origin. However, the manufacturer is Monobind Inc., located in Costa Mesa, CA (USA), and the submission is to the FDA. It is highly probable the data is from the USA. The study used specimens "from low to elevated populations," indicating a range of clinical samples.
Retrospective or Prospective: Not explicitly stated, but clinical comparison studies for 510(k) submissions are typically prospective or involve retrospectively collected samples that are then prospectively tested with both devices. The phrase "clinical comparison... using 128 specimens" suggests these were real-world samples tested with both methods.

3. Number of Experts and Qualifications:

Not applicable for this type of device and study. The ground truth itself is established by the predicate device's measurement, not by expert consensus on visual assessment or interpretation. For an in vitro diagnostic (IVD) device like an ELISA kit, the "ground truth" for the comparison study is the result from the established, legally marketed predicate device.

4. Adjudication Method:

Not applicable. This is a quantitative measurement device comparison, not an interpretation task requiring adjudication. The "ground truth" is the numerical result from the predicate device.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is an in vitro diagnostic (IVD) device that provides a quantitative measurement of a biomarker in a sample, not an imaging or diagnostic interpretation device where human readers are involved. Therefore, there is no "human reader" component to improve in this context.

6. Standalone Performance:

Yes, a standalone performance study was done in the sense that the Monobind ELISA kit generated its own quantitative results independent of human interpretation. The study then compared these standalone results to those of the predicate device. The performance characteristics reported (mean values, recovery, linearity) are standalone performance metrics of the Monobind ELISA.

7. Type of Ground Truth Used:

The ground truth for the comparison was the measurement obtained from the legally marketed predicate device, the Ciba Corning ACS 180 chemiluminescence (ICMA) test. This is an accepted method for demonstrating substantial equivalence for IVDs.

8. Sample Size for the Training Set:

The document does not explicitly mention a "training set" in the context of an algorithm or machine learning. For an ELISA kit, "training" might refer to assay development and optimization rather than a separate dataset for an algorithm. The reported 128 specimens were used for the clinical comparison/validation study. There is no indication of a separate training set for a machine learning model.

9. How the Ground Truth for the Training Set was Established:

As there is no explicit mention of a "training set" for an algorithm, this question is not directly applicable. If one considers the process of developing and optimizing the ELISA kit itself (which could be loosely termed "training" for a traditional assay), the "ground truth" would be established by various biochemical and analytical methods to ensure the assay accurately detected and quantified FSH in reference materials and spiked samples. This would precede the formal clinical comparison study.

Summary

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K 4"1A 120

Image /page/0/Picture/1 description: The image shows a logo for MONOBIND, INC. The logo features a stylized, interconnected design that resembles the letters 'M' and 'B'. Below the logo, the text "MONOBIND, INC." is printed in a bold, sans-serif font. The date "Jul. 11, 97" is printed below the company name.

SEP - 2 1997

510(k) Summarv

Dear Sir:

The proprietary name is Follicle-stimulating hormone (FSH) ELISA and the usual name is FSH ELISA. This device classification name is - follicle-stimulating hormone test system product code CGJ (per 21 CRF section 862.1300).

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 Intended use of the device: The quantitative determination of follicle-stimulating hormone (FSH) concentration in human serum and plasma by a microplate enzymelmmunoassay. Measurements of FSH are used in the diagnosis of pituitary gland and gonadotropin disorders.

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.

Substantial equivalency was based on clinical comparison (linear regression), using 128 specimens from low to elevated populations. The values ranged from 0.1 - 133 mlU/ml.The mean values for reference method (ICMA) and this method (microplate ELISA) are 21.0 mlU/ml and 18.0 mlU/ml respectively. The equation to a straight-line [y= 0.93 (x) - 1.5 ) and correlation coefficient (0.994) indicates good method agreement.

In addition recovery data demonstrated an average recovery of 99.9% when exogenous added follicle-stimulating hormone was introduced into human serum specimens. Similarly, linearity studies showed an average 93.8% when specimens were diluted and compared to the dose response curve.

729 West 16" Street , Costa Mesa , CA (USA) 92627 Phone: (714) 642-4830 FAX: (714) 650-8459

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

SEP - 2 1997

Re : K972720 Follicle Stimulating Hormone (FSH) ELISA Requlatory Class: I Product Code: CGJ Dated: July 14, 1997 Received: July 21, 1997

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 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 requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical General requlation (21 CFR Part 320) and that, Devices: 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 In addition, FDA may publish further announcements action. 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 (770) 488-7655.

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 Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

sincerely yours,
Steven Ditman

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):

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Device Name: Follicle Stimulating Hormone (FSH) Microplate EIA

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number	K972720

Prescription Use		OR	Over-The-Counter Use
(Per 21 CFR 801.109)			(Optional Folmat 1-2-96)

Regulation Number and Section

§ 862.1300 Follicle-stimulating hormone test system.

(a)
Identification. A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.