(121 days)
The GSA kit is for the evaluation of human semen and provides a set of reagents to evaluate semen quality by measuring five parameters, recommended by the World Health Organization (WHO), that are used to determine whether infertility is caused by abnormalities of one or more of them. The parameters include: Sperm Count, sperm motility, sperm viability, white blood cell (WBC) count, and Sperm head morphology (the subject of this 510(k) submission.
Not Found
This looks like a 510(k) clearance letter for a medical device called the "General Semen Analysis Kit" (GSA Kit). However, the provided text does not contain the acceptance criteria or a study detailing device performance against those criteria.
The document primarily states that the FDA has reviewed the 510(k) premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It also outlines the intended use of the GSA kit for evaluating human semen based on five WHO-recommended parameters (Sperm Count, sperm motility, sperm viability, white blood cell (WBC) count, and Sperm head morphology).
To answer your questions, I would need access to the actual 510(k) submission document or a summary of its contents that details the performance studies.
Therefore, I cannot provide the requested information based on the provided input.
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Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dyn-Bioshaf (2006) Ltd. C/O Thomas M. Tsakeris Devices & Diagnostics Consulting Group, Inc. 16809 Briardale Road Rockville, Maryland 20855
OCT 2 5 2007
Re: K071737
Trade/Device Name: General Semen Analysis Kit Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code:GKZ Dated: June 26, 2007 Received: June 26, 2007
Dear Mr. Tsakeris:
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 either class II (Special Controls) or class III (PMA), 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); 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
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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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Robert H. Borker/
Robert L. Becker, Jr., M.D., Ph.D. Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K071737
Device Name: General Semen Analysis (GSA) Kit
Indication for Use:
The GSA kit is for the evaluation of human semen and provides a set of reagents to evaluate semen quality by measuring five parameters, recommended by the World Health Organization (WHO), that are used to determine whether infertility is caused by abnormalities of one or more of them.
The parameters include: Sperm Count, sperm motility, sperm viability, white blood cell (WBC) count, and Sperm head morphology (the subject of this 510(k) submission.
Prescription Use X And/Or (21 CFR Part 801 Subpart D)
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Touphine Bautista
Division Sign/Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K071737
§ 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.”