Cleared Traditional

K930878 - BACTIDROP(TM) MUCAP

K930878 is the FDA 510(k) clearance for BACTIDROP(TM) MUCAP by Remel Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K930878 · Remel Co. · Microbiology device
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May 1993
Decision
81d
Days
Class 1
Risk

K930878 is an FDA 510(k) clearance for the BACTIDROP(TM) MUCAP. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on May 11, 1993 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 Remel Co. devices

Submission Details

510(k) Number K930878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1993
Decision Date May 11, 1993
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.

Device Classification

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 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K930878.
NINHYDRIN REAGENT
K931862 · Hardy Diagnostics · Jun 1993
OXYSTRIP
K930693 · Hardy Diagnostics · May 1993
CATALASE REAGENT
K931414 · Hardy Diagnostics · May 1993
FERRIC CHLORID REAGENT, 10%
K931413 · Hardy Diagnostics · May 1993
NITRATE REAGENTS A, B AND C
K930717 · Hardy Diagnostics · Apr 1993
INDOLE SPOT & INDOLE KOVACS REAGENT
K930718 · Hardy Diagnostics · Apr 1993