Cleared Traditional

BACTIGEN(R) N. MENINGITIDIS (K885004) - FDA 510(k) Clearance

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

K885004 · Armkel, LLC · Microbiology device
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Feb 1989
Decision
68d
Days
Class 2
Risk

K885004 is an FDA 510(k) clearance for the BACTIGEN(R) N. MENINGITIDIS. Classified as Antisera, All Groups, N. Meningitidis (product code GTJ), Class II - Special Controls.

Submitted by Armkel, LLC (Cranbury, US). The FDA issued a Cleared decision on February 7, 1989 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Armkel, LLC devices

Submission Details

510(k) Number K885004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1988
Decision Date February 07, 1989
Days to Decision 68 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 102d · This submission: 68d
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 K885004.
DIRECTIGEN MENINGITIS COMBO TEST
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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