Cleared Traditional

K912480 - BBL(R) DMACA INDOLE REAGENT DROPPERS

K912480 is an FDA 510(k) clearance for BBL DMACA INDOLE REAGENT DROPPERS, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Microbiology device with product code JTO cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K912480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1991
Decision
81d
Days
Class 1
Risk

K912480 is an FDA 510(k) clearance for the BBL(R) DMACA INDOLE REAGENT DROPPERS. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lake, US). The FDA issued a Cleared decision on August 23, 1991 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 - K912480

510(k) Number K912480 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1991
Decision Date August 23, 1991
Days to Decision 81 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 102d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

JTO Device Classification - Class 1, General Controls

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 196
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K912480.
BACTIDROP(TM) DESOXYCHOLATE (10%)
K913001 · Remel Co. · Sep 1991
BACTIDROP(TM) SPOT INDOLE
K913004 · Remel Co. · Sep 1991
BACTIDROP(TM) INDOLE (KOVACS)
K913009 · Remel Co. · Sep 1991
LAP DISCS
K905472 · Carr-Scarborough Microbiologicals, Inc. · Feb 1991
M. CAT. BUTYRATE DISC
K905666 · Carr-Scarborough Microbiologicals, Inc. · Feb 1991
NITRATE DISK
K905163 · Remel Co. · Feb 1991