QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS

• K Number: K063864
• Device Name: QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
• Manufacturer: MEDICAL ELECTRONIC SYSTEMS LTD.
• Date Cleared: 2007-03-26 ( 87 days)
• Product Code: POV , GKZ
• Regulation Number: 864.5220
• Type: Traditional
• Panel: HE
• Reference & Predicate Devices: N/A

Intended Use

QwikCheck™ Test Strips are for in vitro diagnostic use for the determination of pH and leukocytes (WBCs) in semen. Test results are determined by comparing the color of the test patches to the color chart provided on the bottle label. The test is for professional use only.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter for the QwikCheck™ Test Strips, which are reagent strips for semen analysis. However, it does not contain the detailed acceptance criteria and study data needed to fully answer your request.

Specifically, the letter confirms that the device is substantially equivalent to a legally marketed predicate device, but it does not provide:

• A table of acceptance criteria and reported device performance.
• Details about samples, experts, or ground truth establishment.
• Information regarding standalone performance, MRMC studies, or training set details.

The letter focuses on regulatory approval based on substantial equivalence, rather than a detailed performance study report. To get the information you're looking for, you would typically need to review the original 510(k) submission document itself, or any accompanying performance study reports that were submitted to the FDA for review.

Regulation Number and Section

§ 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.”