Cleared Traditional

K860768 - DIRECTIGEN COMBO MENINGITIS TEST

K860768 is an FDA 510(k) clearance for DIRECTIGEN COMBO MENINGITIS TEST, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code GTZ cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K860768 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1986
Decision
71d
Days
Class 1
Risk

K860768 is an FDA 510(k) clearance for the DIRECTIGEN COMBO MENINGITIS TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Paramus, US). The FDA issued a Cleared decision on May 13, 1986 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3740 - 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

FDA 510(k) Submission Details - K860768

510(k) Number K860768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1986
Decision Date May 13, 1986
Days to Decision 71 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
31d faster than avg
Panel avg: 102d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

GTZ Device Classification - Class 1, General Controls

Product Code GTZ Antisera, All Groups, Streptococcus Spp.
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.3740
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GTZ Antisera, All Groups, Streptococcus Spp.

All 89
Devices cleared under the same product code (GTZ) and FDA review panel - the closest regulatory comparables to K860768.
BINAX STREP A
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CARDS(TM) STREP A CATALOG NO. CR-7545
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SEROIDEN STREPTO KIT 'EIKEN'
K861098 · Syn-Kit, Inc. · Aug 1986
LEECO-SCREEN, STREP A (EIA)
K860947 · Leeco Diagnostics, Inc. · May 1986
TANDEM ICON STREP A IMMUNOENZYMETRIC ASSAY KIT
K860778 · Hybritech, Inc. · Apr 1986
DIFCO STREP A LATEX TEST
K854978 · Difco Laboratories, Inc. · Mar 1986