Cleared Traditional

SLIDEX MENINGITE-KIT 5 (K910210) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K910210 · Vitek Systems, Inc. · Microbiology device
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Aug 1991
Decision
209d
Days
Class 2
Risk

K910210 is an FDA 510(k) clearance for the SLIDEX MENINGITE-KIT 5. Classified as Antisera, All Groups, N. Meningitidis (product code GTJ), Class II - Special Controls.

Submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 12, 1991 after a review of 209 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3390 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Vitek Systems, Inc. devices

Submission Details

510(k) Number K910210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1991
Decision Date August 12, 1991
Days to Decision 209 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 102d · This submission: 209d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GTJ Antisera, All Groups, N. Meningitidis
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3390
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GTJ Antisera, All Groups, N. Meningitidis

All 15
Devices cleared under the same product code (GTJ) and FDA review panel - the closest regulatory comparables to K910210.
DIRECTIGEN MENINGITIS COMBO TEST
K952791 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1996
DIRECTIGEN MENINGITIS COMBO TEST KIT
K915330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1992
DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST
K844407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1985