Cleared Traditional

K812808 - BBL DIRECTIGEN TEST KIT (FDA 510(k) Clearance)

Class I Microbiology device.

K812808 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Dec 1981
Decision
85d
Days
Class 1
Risk

K812808 is an FDA 510(k) clearance for the BBL DIRECTIGEN TEST KIT. Classified as Antigens, All Groups, Streptococcus Spp. (product code GTY), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on December 30, 1981 after a review of 85 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 K812808 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1981
Decision Date December 30, 1981
Days to Decision 85 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 102d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GTY Antigens, 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.