Cleared Traditional

BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA (K881115) - FDA 510(k) Clearance

Class I Microbiology device.

K881115 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
9d
Days
Class 1
Risk

K881115 is an FDA 510(k) clearance for the BACTEC(R) NR26 AND BACTEC(R) NR 27 CULTURE MEDIA. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on March 24, 1988 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2300 - 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 K881115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1988
Decision Date March 24, 1988
Days to Decision 9 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
93d faster than avg
Panel avg: 102d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 60
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K881115.
TRYPTOSE BLOOD AGAR BASE
K881562 · Acumedia Manufacturers, Inc. · Apr 1988
TRYPTOSE PHOSPHATE BROTH
K881563 · Acumedia Manufacturers, Inc. · Apr 1988
TRYPTOSE BLOOD AGAR BASE W/YEAST EXTRACT
K881564 · Acumedia Manufacturers, Inc. · Apr 1988
ANAEROBIC BLOOD AGAR (CDC FORMULATION)
K871089 · bioMerieux, Inc. · Apr 1987
TRYPTIC SOY AGAR
K871098 · bioMerieux, Inc. · Apr 1987
SEPTI-CHEK TSB W/SUCROSE BLOOD CULTURE BOTTLE-ROCH
K851250 · Roche Diagnostic Systems, Inc. · Apr 1985