Willcogen Meningitidis Kit ZL25

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K851691 ↗

FDA Product Code

GTJ

Device Class

Class II

Regulation

21 CFR Part 866.3390

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Wellcome Diagnostics →

• What specific types of *Neisseria meningitidis* can this kit identify, and how does it help in clinical decision-making?

  The Willcogen Meningitidis Kit ZL25 is designed to identify and differentiate *Neisseria meningitidis* serogroups through serological testing. This aids clinicians in microbiology labs by confirming the presence of meningococcal bacteria, which is critical for diagnosing meningitis or meningococcal disease. Accurate identification helps guide appropriate antimicrobial therapy and infection control measures.

• Is this kit meant for single-use only, and if so, why is that important for laboratory workflows?

  Yes, the Willcogen Meningitidis Kit ZL25 is supplied as a single-use diagnostic reagent. This ensures sterility and consistency in test results, as reuse could introduce contamination or variability. For laboratories, single-use minimizes cross-contamination risks, reduces the need for reprocessing, and aligns with standard microbiological testing protocols for accuracy and safety.

• What kind of laboratory setting is this kit intended for, and does it require specialized equipment or training?

  This kit is cleared for use in microbiology laboratories, where trained personnel perform serological testing. While the kit itself is designed for routine microbiological use, proficiency in handling antisera reagents and interpreting serological results is assumed. Laboratories should ensure staff are familiar with standard microbiological practices, as the kit requires laboratory processing rather than point-of-care or non-laboratory use.

• How does the FDA’s classification and clearance pathway for this device impact its use in clinical practice?

  The Willcogen Meningitidis Kit ZL25 is classified under FDA product code GTJ and regulatory category 866.3390, with clearance via the Traditional 510(k) pathway (decision date: June 10, 1985). This classification confirms it is a Class II device, meaning it has moderate risk and requires performance standards or special controls. Clinically, this clearance ensures the kit meets FDA’s requirements for safety and effectiveness in identifying *Neisseria meningitidis* serogroups, supporting its reliability in microbiology labs for diagnostic purposes.