(58 days)
No
The summary does not mention AI, ML, or image processing, and the device description points to electro-optical technology for analysis.
No
The device is used for semen analysis and provides calculated measurements related to sperm, indicating a diagnostic purpose rather than a therapeutic one.
Yes.
The device provides "calculated measurements for: total cell concentration, percent motility, normal morphology, motile sperm concentration, functional sperm concentration, and sperm motility index," which indicates its use in analyzing and characterizing a patient's semen, thereby aiding in diagnosis.
No
The device description explicitly states it is an "electro-optical device," indicating the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device is intended for "semen analysis," which involves testing a biological sample (semen) in vitro (outside the body) to provide diagnostic information (measurements of sperm characteristics).
- Device Description: It's described as an "electro-optical device for semen analysis," further confirming its use in analyzing a biological sample.
- Measurements: The device provides calculated measurements for various parameters of semen, which are used to assess fertility and diagnose related conditions.
The fact that it analyzes a biological sample in vitro to provide diagnostic information is the key characteristic of an IVD.
N/A
Intended Use / Indications for Use
The SQA is a point-of-care, easy-to-use, electro-optical device for semen analysis. The SQA provides calculated measurements for:
- total cell concentration (millions/mL)
- percent (%) motility
- % normal morphology
- motile sperm concentration (MSC), (millions/mL)
- functional sperm concentration (FSC), (millions/mL)
- sperm motility index (SMI)
Product codes
GKZ
Device Description
The SQA is a point-of-care, easy-to-use, electro-optical device for semen analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
electro-optical
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
point-of-care
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the symbol. The caduceus is black, and the text is also black. The logo is simple and recognizable, representing the department's mission to protect the health of all Americans.
10903 New Hampshire Avenue Silver Spring, MD 20993
Medical Electronics Systems, LLC c/o Ms. Erika B. Ammirati, RAC, MT(ASCP) Regulatory Consultant 575 Shirlynn Court Los Altos, California 94022
DEC 2 1 2012
Re: K012352
Trade/Device Name: Medical Electronics Systems, LLC, Sperm Quality Analyzer (SQA) Regulation Number: 21 CFR § 864.5220 Regulation Name: Automated differential cell counter Regulatory Class: Class II Product Code: GKZ Date: July 23, 2001 Received: July 25, 2001
Dear Ms. Ammirati:
This letter corrects our substantially equivalent letter of September 21, 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 (reporting of
1
Page 2 - Ms. Erika Ammirati
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/ReportalProblem/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,
m chan
Maria M. Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
July 23, 2001
Medical Electronic Systems, LLC SOA, Sperm Quality Analyzer 510(k) Modification for K894949
STATEMENT OF INTENDED USE
Kola352 510(K) Number (if known): __
Device Name: SQA, Sperm Quality Analyzer
Indications for Use:
The SQA is a point-of-care, easy-to-use, electro-optical device for semen analysis. The SQA provides calculated measurements for:
- total cell concentration (millions/mL) t
- . percent (%) motility
- % normal morphology .
- motile sperm concentration (MSC), (millions/mL) ●
- functional sperm concentration (FSC), (millions/mL) .
- sperm motility index (SMI) ●
Aruseline Bautista
Clinical Laboratory Devices
510(k) Number K012352
(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 | |
---|---|
---------------------- | -- |