(87 days)
Not Found
No
The device description and intended use clearly describe an immunochromatographic test, which is a chemical-based assay, not a technology that typically incorporates AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No
Explanation: This device is for diagnostic purposes, aiding vasectomized men by detecting sperm concentration. It does not treat or cure any condition.
Yes
This device is a diagnostic device as it is a qualitative test designed to detect low concentrations of sperm, aiding vasectomized men, which falls under the definition of diagnosing a physical condition.
No
The device description clearly states it is an "immunochromatographic test," which is a physical test kit, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For in vitro OTC home use." This indicates the test is performed outside of the body (in vitro) on a biological sample (human semen).
- Device Description: The description confirms it's an "immunochromatographic test for the rapid, qualitative detection of sperm concentration." This is a common type of in vitro diagnostic test.
- Anatomical Site: The test is performed on "human semen," which is a biological sample.
- Intended User / Care Setting: "in vitro, over the counter home use" further reinforces that the test is performed outside of a clinical setting on a biological sample.
The definition of an IVD is a medical device that is used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. This device fits that definition by examining a semen sample to aid in monitoring for vasectomized men.
N/A
Intended Use / Indications for 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 OTC home use.
Product codes (comma separated list FDA assigned to the subject device)
GKZ
Device Description
SpermCheck® Vasectomy is an immunochromatographic test for the rapid, qualitative detection of sperm concentration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
For in vitro, over the counter home use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5220 Automated differential cell counter.
(a)
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.(b)
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.”
0
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:
- Date of Summary: October 18, 2007
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- Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone: 732-274-1000 Fax: 732-274-1010
JAN 2 4 2008
- Submitted by: Princeton BioMeditech Corporation 4242 U.S. Route 1, Monmouth Jct., NJ 08852 Phone: 732-274-1000 Fax: 732-274-1010
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- Device Name: Trade Names: SpermCheck® Vasectorny Common or Usual Name: Semen analysis test device Classification Name: Obstetrics/gynecology
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- Device Description: SpermCheck® Vasectomy is an immunochromatographic test for the rapid, qualitative detection of sperm concentration.
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- 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.
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- 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.
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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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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Office of In Vitro Diagnostic Device Evaluation and Safety
(32) K073039