(43 days)
Not Found
Not Found
No
The summary describes a quality control material for sperm analysis systems and manual counting methods. There is no mention of AI, ML, image processing, or any other technology that would suggest the use of AI/ML.
No
Explanation: The device is intended for in-vitro diagnostic use as quality control material for sperm concentration, not for treating any medical condition.
Yes
The device is described as "intended for in-vitro diagnostic use as sperm concentration quality control material". While it is a quality control material and not directly diagnosing a patient, it is used within a diagnostic process to ensure the accuracy of diagnostic measurements.
No
The device is described as "sperm concentration quality control material," which implies a physical substance (beads) used for calibration or quality control of other devices. This is not a software-only device.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
The key phrase that confirms this is:
- "QwikCheck-beads™ is intended for in-vitro diagnostic use..."
This statement explicitly declares the intended use of the device as in-vitro diagnostic.
N/A
Intended Use / Indications for Use
QwikCheck-beads™ is intended for in-vitro diagnostic use as sperm concentration quality control material for the SQA-V system (MES Ltd., Israel) in both the automated and manual visualization modes, as well as non-instrumented sperm cell counting chambers such as the hemacytometer (Neubauer type), and the non-dilutional chamber (Makler type).
Product codes
JJW, NRF
Device Description
Not Found
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
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/0/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Re:
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Medical Electronics Systems Ltd. c/o Ms. Erika B. Ammirati Regulatory Consultant to MES Ltd. 575 Shirlynn Court Los Altos, CA 94022
K041600 Trade/Device Name: OwikCheck- beads™ Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJW, NRF Dated: May 31, 2004 Received: June 14, 2004
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.
JUL 27 2004
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 predicate device results in a classification for your device and thus, permits your device to proceed to the market.
1
Page 2
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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Jean M. Cooper, MS, DVM.
Tean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
STATEMENT OF INTENDED USE
510(K) Number (if known): K041600
Device Name: QwikCheck-beads™
Indications for Use:
QwikCheck-beads™ is intended for in-vitro diagnostic use as sperm concentration quality control material for the SQA-V system (MES Ltd., Israel) in both the automated and manual visualization modes, as well as non-instrumented sperm cell counting chambers such as the hemacytometer (Neubauer type), and the non-dilutional chamber (Makler type).
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE AS NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use レ (Per 21 CFR 801.109)
OR Over-the-Counter Use
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Ku41602