Cleared Traditional

K844407 - DIRECTIGEN NEISSENA MENNINGITIDIS GROUP...

K844407 is the FDA 510(k) clearance for DIRECTIGEN NEISSENA MENNINGITIDIS GROUP... by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 2 Microbiology device (product code GTJ) cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K844407 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Jan 1985
Decision
73d
Days
Class 2
Risk

K844407 is an FDA 510(k) clearance for the DIRECTIGEN NEISSENA MENNINGITIDIS GROUP B TEST. Classified as Antisera, All Groups, N. Meningitidis (product code GTJ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 25, 1985 after a review of 73 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K844407 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1984
Decision Date January 25, 1985
Days to Decision 73 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 102d · This submission: 73d
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 13
Devices cleared under the same product code (GTJ) and FDA review panel - the closest regulatory comparables to K844407.
PHADEBACT CSF TEST
K844999 · Pharmacia, Inc. · Oct 1985
WILLCOGEN MENINGITIDIS KIT ZL25
K851691 · Wellcome Diagnostics · Jun 1985
MENINGOCOCCUS GROUP B MONOCLONAL ANTIBODY ZM-51
K844762 · Wellcome Diagnostics · Jun 1985
BACTIGEN - N.MENNINIGITIDIS TEST
K841907 · Armkel, LLC · Jul 1984
WELLCOGEN N. MENINGITIDIS A,C,Y W135
K833063 · Wellcome Diagnostics · Jan 1984
BACTIGEN-N. MENINGITIDIS
K823880 · Armkel, LLC · Mar 1983