SPERMCHECK VASECTOMY

K073039 · Princeton BioMeditech Corp. · POV · Jan 24, 2008 · Hematology

Device Facts

• Record ID: K073039
• Device Name: SPERMCHECK VASECTOMY
• Applicant: Princeton BioMeditech Corp.
• Product Code: POV · Hematology
• Decision Date: Jan 24, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5220
• Device Class: Class 2

Intended Use

SpermCheck® Vasectomy is a rapid qualitative test that detects low concentrations of sperm at or above 250,000 sperm/mL in human semen as an aid for vasectomized men. For in vitro, over the counter home use.

Device Story

SpermCheck® Vasectomy is an immunochromatographic test for rapid, qualitative detection of sperm concentration in human semen. Designed for OTC home use by men who have undergone a vasectomy. The device detects sperm concentrations at or above 250,000 sperm/mL. The user performs the test at home; results are interpreted qualitatively by the presence or absence of a color indicator. The test serves as an aid to confirm the success of a vasectomy procedure by identifying the presence of residual sperm. It provides a convenient, non-clinical method for monitoring post-vasectomy status.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological principles to predicate devices.

Technological Characteristics

Solid-phase chromatographic immunoassay. Components include nitrocellulose membrane, lyophilized detector antibody conjugated to gold dye, and immobilized capture antibodies. Detects SP10 protein. Ambient temperature operation. Visual readout via colored bands. No electronic components or software.

Indications for Use

Indicated for vasectomized men to qualitatively detect sperm concentration at or above 250,000 sperm/mL in human semen. For OTC home use.

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

• Hemacytometer
• Fertell Male Fertility Test (K041039)
• FertilMARQ™ Male Fertility Test (K011679)

Submission Summary (Full Text)

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## 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR Part 807.92.

The assigned 510(k) number is:

1. Date of Summary: October 18, 2007

- 2. Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone: [phone] Fax: [phone]
JAN 2 4 2008

- 3. Device Name: Trade Names: SpermCheck® Vasectorny Common or Usual Name: Semen analysis test device Classification Name: Obstetrics/gynecology
- 4. Identification of legally marketed devices to which claims of equivalence are made: Hemacytometer K041039, Fertell Male Fertility Test by Genosis Ltd. K011679, FertilMARQTM Home Diagnostic Screening Test for Male Infertility, by Embryotech Laboratories, Inc.
- 5. Device Description: SpermCheck® Vasectomy is an immunochromatographic test for the rapid, qualitative detection of sperm concentration.
- 6. Intended Use: SpermCheck® Vasectorny is a rapid qualitative test that detects low concentrations of sperm at or above 250,000 sperm/mL in human semen as an aid for vasectomized men. For in vitro OTC home use.
- 7. Substantial Equivalence: SpermCheck® Vasectomy is substantially equivalent to standard microscopic analysis (counting by Hemacytometer) based on WHO guidelines in its performance and K041039, Fertell Male Fertility Test manufactured by Genosis Ltd in the principle of the test. Both Fertell Male Fertility and SpermCheck® Vasectomy tests are Chromatographic Immunoassays to detect sperm concentration qualitatively. FertilMARQ™ Home Diagnostic Screening Test for Male Infertility, K011679, is also substantially equivalent in detecting sperm concentration qualitatively by color.
- Conclusion: SpermCheck® Vasectomy is substantially equivalent to standard microscopic analysis (counting by Hemacytometer), K041039; Fertell Male Fertility Test manufactured by Genosis Ltd., and K011679, FertilMARQ™ Home Diagnostic Screening Test for Male Infertility manufactured by Embryotech Laboratories, Inc.

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, overlapping each other. The profiles are surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Princeton BioMeditech Corporation c/o Dr. Kyung-ah Kim Director 4242 US Route 1 Monmouth Junction, NJ 08852

JUN 1 5 2012

Re: k073039

Trade/Device Name: SpermCheck® Vasectomy Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: October 18, 2007 Received: October 29, 2007

Dear Dr. Kim:

This letter corrects our substantially equivalent letter of January 24, 2008.

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 (reporting of

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Page 2 – Dr. Kyung-ah Kim

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,

ia m chen

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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## Indications for Use

510(k) Number (if known):_ 1073039

Device Name: SpermCheck® Vasectomy

Indications For Use:

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SpermCheck® Vasectomy is a rapid qualitative test that detects low concentrations of sperm at or above 250,000 sperm/mL in human semen as an aid for vasectomized men. For in vitro, over the counter home use.

Prescription Use _ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) Over-The-Counter Use __ V

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