(115 days)
The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for:
- total sperm concentration (TSC, millions/mL) .
- percent motility (%MOT) and % progressive motility (%PMOT) .
- % normal morphology (%MORPH) .
- motile sperm concentration (MSC, millions/mL) and progressive MSC (PMSC) ●
- . functional sperm concentration (FSC, millions/mL)
The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis.
This looks like a medical device submission, specifically a 510(k) for a "Sperm Quality Analyzer - Visual (SQA V)". However, the provided document is an FDA letter recognizing substantial equivalence, and an "Indications for Use" statement.
Crucially, this document does NOT contain the acceptance criteria, the study details, or the reported device performance. The FDA letter indicates the device has been found substantially equivalent to a predicate device, which means the company filed a submission with this information, but this specific excerpt does not include it.
To answer your request, I would need to see the actual 510(k) submission summary or a section detailing the performance study. This letter is simply the FDA's regulatory decision based on that submission.
Therefore, I cannot fill out the requested table and answer the specific questions because the necessary information is not present in the provided text.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" around the perimeter. In the center of the seal is a stylized caduceus, which is a symbol of medicine. The caduceus is made up of three lines that curve and intersect. Below the caduceus are two wavy lines, which may represent water or movement.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 2 0 2002
Ms. Erika B. Ammirati Regulatory Consultant Medical Electronic Systems, LLC 269 South Beverly Drive, # 472 Beverly Hills, CA 90212
K021746 Re:
Trade/Device Name: SQA V, Sperm Quality Analyzer - Visual Regulation Number: 21 CFR 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Dated: August 14, 2002 Received: August 15, 2002
Dear Ms. Ammirati:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrlvdsma/dsmamain.html".
Sincerely yours,
Steven Butman
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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STATEMENT OF INTENDED USE
KD21746 510(K) Number (if known):
Device Name: SQA V, Sperm Quality Analyzer - Visual
Indications for Use:
The SQA V is a point-of-care, easy-to-use, electro-optical device with on-screen visualization and image freezing capabilities for semen analysis. The SQA V provides direct and calculated measurements for:
- total sperm concentration (TSC, millions/mL) .
- percent motility (%MOT) and % progressive motility (%PMOT) .
- % normal morphology (%MORPH) .
- motile sperm concentration (MSC, millions/mL) and progressive MSC (PMSC) ●
- . functional sperm concentration (FSC, millions/mL)
Jacqueline Pautrat
(Division Sign-Off)
Division of Clinical Laboratory, Devices
510(k) Number K021746
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over -the-Counter Use
§ 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.”