Cleared Traditional

K072827 - RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE (FDA 510(k) Clearance)

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K072827 · Remel, Inc. · Microbiology device
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Nov 2007
Decision
54d
Days
Class 2
Risk

K072827 is an FDA 510(k) clearance for the RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE. Classified as Culture Media, Antifungal, Susceptibility Test (product code MJE), Class II - Special Controls.

Submitted by Remel, Inc. (Lenexa, US). The FDA issued a Cleared decision on November 26, 2007 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1700 - 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, Inc. devices

Submission Details

510(k) Number K072827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2007
Decision Date November 26, 2007
Days to Decision 54 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 102d · This submission: 54d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MJE Culture Media, Antifungal, Susceptibility Test
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1700
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.