Cleared Traditional

REMEL SPECTRA VRE (K092819) - FDA 510(k) Clearance

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

K092819 · Thermo Fisher Scientific · Microbiology device
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Jul 2010
Decision
304d
Days
Class 2
Risk

K092819 is an FDA 510(k) clearance for the REMEL SPECTRA VRE. Classified as Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar (product code JSO), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Lenexa, US). The FDA issued a Cleared decision on July 15, 2010 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Thermo Fisher Scientific devices

Submission Details

510(k) Number K092819 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2009
Decision Date July 15, 2010
Days to Decision 304 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
202d slower than avg
Panel avg: 102d · This submission: 304d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
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.

Regulatory Peers - JSO Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar

All 39
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K092819.
HardyCHROM CRE
K190553 · Hardy Diagnostics · Apr 2019
CHROMID CARBA agar (CARB)
K181092 · Biomerieux S.A. · Jul 2018
MRSASelect II
K171061 · Bio-Rad · Dec 2017
HAEMOPHILUS TEST MEDIUM (HTM) BROTH
K903425 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1990
HAEMOPHILUS TEST MEDIUM (HTM)AGAR
K894216 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
GAR, COLUMBIA, W/5% HORSE BLOOD
K770441 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1977