Cleared Traditional

K915330 - DIRECTIGEN MENINGITIS COMBO TEST KIT

K915330 is an FDA 510(k) clearance for DIRECTIGEN MENINGITIS COMBO TEST KIT, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Microbiology device with product code GTJ cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K915330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
118d
Days
Class 2
Risk

K915330 is an FDA 510(k) clearance for the DIRECTIGEN MENINGITIS COMBO TEST KIT. Classified as Antisera, All Groups, N. Meningitidis (product code GTJ), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 23, 1992 after a review of 118 days - within the typical 510(k) review window.

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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

FDA 510(k) Submission Details - K915330

510(k) Number K915330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1991
Decision Date March 23, 1992
Days to Decision 118 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 102d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GTJ Device Classification - Class 2, Special Controls

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 14
Devices cleared under the same product code (GTJ) and FDA review panel - the closest regulatory comparables to K915330.
DIRECTIGEN MENINGITIS COMBO TEST
K952791 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1996
SLIDEX MENINGITE-KIT 5
K910210 · Vitek Systems, Inc. · Aug 1991
BACTIGEN(R) N. MENINGITIDIS
K885004 · Armkel, LLC · Feb 1989
WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24
K854851 · Wellcome Diagnostics · Feb 1986
WELLCOGEN BACTERIAL ANTIGEN KIT
K854852 · Wellcome Diagnostics · Feb 1986
PHADEBACT CSF TEST
K844999 · Pharmacia, Inc. · Oct 1985