Cleared Traditional

K871907 - LD PRESUMPTO QUAD

K871907 is an FDA 510(k) clearance for LD PRESUMPTO QUAD, 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 13-day FDA review.

K871907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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May 1987
Decision
13d
Days
Class 1
Risk

K871907 is an FDA 510(k) clearance for the LD PRESUMPTO QUAD. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 28, 1987 after a review of 13 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 - K871907

510(k) Number K871907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1987
Decision Date May 28, 1987
Days to Decision 13 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
89d faster than avg
Panel avg: 102d · This submission: 13d
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 154
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K871907.
DIFCO OXIDASE DRYSLIDE
K896398 · Difco Laboratories, Inc. · Dec 1989
ROSCO PYRR
K894221 · Pro-Lab, Inc. · Sep 1989
PYR/ESCULIN DISK
K880950 · Remel Co. · Apr 1988
GEN-PROBE BETA-LACTAMASE TEST KIT
K870422 · Gen-Probe, Inc. · Apr 1987
SPOTTEST 10% SODIUM DESOXYCHOLATE
K870716 · Difco Laboratories, Inc. · Apr 1987
SPOTTEST MICRODASE
K870717 · Difco Laboratories, Inc. · Apr 1987