Cleared Traditional

K870155 - DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST (FDA 510(k) Clearance)

Class I Microbiology device.

K870155 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Mar 1987
Decision
56d
Days
Class 1
Risk

K870155 is an FDA 510(k) clearance for the DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST. Classified as Antisera, All Groups, Streptococcus Spp. (product code GTZ), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 10, 1987 after a review of 56 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

Submission Details

510(k) Number K870155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1987
Decision Date March 10, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 102d · This submission: 56d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.