FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY

K011679 · Embryotech Laboratories, Inc. · POV · Aug 15, 2001 · Hematology

Device Facts

• Record ID: K011679
• Device Name: FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
• Applicant: Embryotech Laboratories, Inc.
• Product Code: POV · Hematology
• Decision Date: Aug 15, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

The FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is a rapid test of your semen for sperm concentration. It will measure sperm as either above or below the cutoff of 20 million sperm cells per milliliter (mL). Two test results of less than 20 million cells/mL are an indicator of male infertility.

Device Story

FertilMARQ is an in vitro diagnostic test kit for home or clinic use to screen male sperm concentration. Input: semen sample. Process: liquefaction in Chymotrypsin-coated cup; filtration in test cassette; staining with Thiazine Blue reagent. Output: colorimetric result on test cassette. Operation: user compares test well color to reference control well. Result: semi-quantitative determination of sperm concentration relative to 20 million/mL cutoff. Benefit: provides rapid screening for male infertility; assists in clinical decision-making by identifying need for further professional evaluation.

Clinical Evidence

Clinical study at three sites with 197 semen samples compared lay user results to professional technician results. Results: 88% concurrence, 11% discordant, 1% unreportable. Performance metrics (professional as truth): Sensitivity 94%, Specificity 61%, Positive Predictive Value 89%, Negative Predictive Value 75%, Accuracy 78%.

Technological Characteristics

In vitro diagnostic test kit. Components: Chymotrypsin-coated collection cups, disposable droppers, test cassettes. Staining reagent: Thiazine Blue. Principle: filtration separation and colorimetric staining. Storage: room temperature. No electronic or software components.

Indications for Use

Indicated for use by individuals to screen semen for sperm concentration. The test identifies if sperm concentration is above or below 20 million cells/mL. Two results below 20 million cells/mL indicate potential male infertility.

Regulatory Classification

Identification

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

Special Controls

*Classification.* Class II (special controls). The special control for this device is the FDA document entitled “Class II Special Controls Guidance Document: Premarket Notifications for Automated Differential Cell Counters for Immature or Abnormal Blood Cells; Final Guidance for Industry and FDA.”

Predicate Devices

• Embryotech FertilMARQ™ Test Kit (K983473)

Submission Summary (Full Text)

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EMBRYOTECH

l a b o r a t o r i e s

## 510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 AND 21 CFR 807.92.

KO 11679 The assigned 510 (k) number is:

Embryotech Laboratories, Inc. (A)(1) Submitter's name:

> 323 Andover Street, Submitter's address: Wilmington, MA 01887

> Submitter's telephone number: [phone]

Contact Person:

Ann D. McGonigle, Regulatory Affairs consultant to Embryotech Laboratories [phone]

Date Summary Prepared: May 21, 2001

FertilMARQ™ Home Diagnostic Screening (2) Trade or proprietary device name: Test Kit for Male Infertility Common or usual name: Semen analysis test kit Obstetrics/gynecology Classification name: (3) Legally marketed predicate device: Embryotech FertilMARQ™ Test Kit

(3) Legally marketed predicate device: Embry
[Embry

[Embryotech Laboratories, Inc. (K983473, 12/17/98)]

(4) Subject device description:

The FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility is an in vitro test kit for the analysis of sperm concentration. Each kit provides sufficient components to perform analysis of two separate semen samples. The kit contains components intended for collection, preparation and testing of semen samples (pre-coated collection cups, disposable droppers, test cassettes), and the reagents to stain and wash semen samples on the test cassette. A package insert that includes a FertilMARQ Sperm Concentration Test Results form is included in the Kit. The Kit and all components are stored at room temperature.

The Kit test cassette has four wells and allows the user to perform two separate tests. For each test, there is reference color control well and an adjacent test well provided. There are two sets of reference color wells and adjacent test wells on the cassette.

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## EMBRYOTECH™

## l a boratories

- (5) Subject device Intended use:
The FertilMARQTM Home Diagnostic Screening Test Kit for Male Infertility is a rapid test of your semen for sperm concentration. It will measure sperm as either above or below the cutoff of 20 million sperm cells per milliliter (mL). Two test results of less than 20 million cells/mL are an indicator of male infertility.

- (6) Test Characteristics:
The test operates by liquefaction of sperm ejaculate in a Chymotrypsin-coated cup, then filtration separation of sperm from seminal plasma and other semen components in the cassette test well(s). The staining reagent (Thiazine Blue) added to sample reacts with multiple components present in the differentiated sperm to provide an average signal that is representative of the entire sperm population. Hundreds of thousands to millions of sperm cells are captured in the test well cassette filter. The semi-quantitative test yields a colorimetric result indicating sperm concentration as above or below 20 million/mL (20 M/mL) sperm. This determination is made by visual interpretation, comparing test sample well color to the reference control well.

(B) (1) Studies establishing Substantial Equivalence

- (a) The design and performance of the kit are essentially the same as the predicate device. Therefore no additional kit performance studies were performed.
- (b) Results from data of clinical studies at three sites were pooled. Comparison was made between results of subjects (lay users) versus those of professional user with the FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility. Each subject produced a semen sample, tested the sample using the FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility, then provided an aliquot to be tested with the kit by a professional (lab technician) .. Lay users performed the test either at home or at the clinic. Both users groups had no prior experience with the kit. Pooled data of 197 semen samples showed 88% concurrence between lab technicians and lay users, with 11% discordant and 1 % unreportable.

Further analysis of the data was performed, treating professional results as truth.

| True positives = | Semen samples with sperm concentrations measured by professionals above 20 million/mL |
|------------------|---------------------------------------------------------------------------------------|
| True negatives = | Semen samples with sperm concentrations measured by professionals below 5 million/mL |

True negatives = Semen samples with sperm concentrations measured by professionals less than 20 million/mL

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# EMBRYOTECH™

## l a b o r a t o r i e s

### True Negative results

#### True Positive results

Site 1: 14 /79 < 20 M/mL by professional user Site 2: 9 /43 < 20 M/mL professional user Site 4: 13/72 < 20 M/mL by professional user

65 /79 > 20 M/mL by professional user 34 /43 > 20 M/mL by professional user 59 /72 > 20 M/mL by professional user

36/194 < 20 M/mL

158/194 > 20 M/mL

- Out of 158 true positives, home users correctly identified 141 as positive (Positive predictive value = 89%).
- (1 ostere productives, home users correctly identified 27 as negative (Negative predictive value = 75%)

Calculated Contingency results:

| Sensitivity = 94% | Positive predictive Value = 89% |
|-------------------|---------------------------------|
| Specificity = 61% | Negative predictive value = 75% |
| Accuracy = 78% | |

### (2)

Conclusions of Comparison studies

Results obtained on semen samples analyzed by both professional and lay user using the FertilMARQ™ Home Diagnostic Screening Test Kit for Male Infertility using the Fertilur HQ - Home Drigally equivalent to the predicate device and demonstrated that the RT is buotcain.nl , equalifical , square for use given and obtain comparable results to professional findings.

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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 features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle, there is a stylized image of an eagle with three human profiles incorporated into its design.

10903 New Hampshire Avenue Silver Spring, MD 20993

Embryotech Laboratories, Inc. c/o Ms. Ann D. McGonigle Regulatory Consultant 323 Andover Street Wilmington, MA 01887

JUN 1 5 2012

Re: k011679

Trade/Device Name: FertilMARQ™ Home Diagnostic Screening Test for Male Infertility Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: May 21, 2001 Received: May 30, 2001

Dear Ms. McGonigle:

This letter corrects our substantially equivalent letter of August 15, 2001.

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 class II (Special Controls), 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); medical device reporting of

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Page 2 - Ms. Ann D. McGonigle

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 advice for your device on our labeling regulation (21 CFR Parts 801 and 809), 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" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,
manei m Chan

Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## C. Indications for use of the Device

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Page 1 of 1

510(k) Number:

.

FertilMARQ™ Home Diagnostic Screening Test Kit for Male Device Name: Infertility

Indications for Use:

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(Please do not write below this line-continue on another page if needed)

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K011679 |
| Prescription Use (Optional Format 1-2-96) | <img alt="Prescription Use" src="prescription_use.png"/> |
| or Over-the-Counter Use | <img alt="Over-the-Counter Use" src="over_the_counter_use.png"/> (Per 21 CFR 801.109) |

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