QWIKCHECK-BEADS

K041600 · Medical Electronics Systems , Ltd. · NRF · Jul 27, 2004 · Hematology

Device Facts

• Record ID: K041600
• Device Name: QWIKCHECK-BEADS
• Applicant: Medical Electronics Systems , Ltd.
• Product Code: NRF · Hematology
• Decision Date: Jul 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended 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).

Device Story

QwikCheck-beads™ serves as a quality control material for sperm concentration analysis. It is used in clinical laboratory settings to verify the accuracy and precision of the SQA-V automated sperm quality analyzer, as well as manual counting methods including hemacytometers and Makler chambers. The beads mimic sperm cells to provide a standardized reference for concentration measurements. Healthcare professionals use the output to validate instrument performance and ensure reliable diagnostic results for semen analysis, thereby supporting accurate clinical assessment of male fertility.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Quality control material consisting of standardized beads designed to simulate sperm cells for concentration counting. Compatible with automated (SQA-V) and manual (hemacytometer, Makler chamber) counting methods.

Indications for Use

Indicated for in-vitro diagnostic use as a quality control material for monitoring the performance of sperm concentration measurements in the SQA-V system, hemacytometers (Neubauer type), and non-dilutional chambers (Makler type).

Regulatory Classification

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).

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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