Cleared Traditional

K073027 - SPECTRA MRSA

K073027 is the FDA 510(k) clearance for SPECTRA MRSA by Thermo Fisher Scientific. It is a Class 2 Microbiology device (product code JSO) cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K073027 · Thermo Fisher Scientific · Microbiology device
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
125d
Days
Class 2
Risk

K073027 is an FDA 510(k) clearance for the SPECTRA MRSA. 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 February 28, 2008 after a review of 125 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 K073027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 2007
Decision Date February 28, 2008
Days to Decision 125 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
23d slower than avg
Panel avg: 102d · This submission: 125d
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 28
Devices cleared under the same product code (JSO) and FDA review panel - the closest regulatory comparables to K073027.
CHROMID VRE AGAR, MODEL: REF 43 851
K091025 · bioMerieux, Inc. · Mar 2010
CHROMID MRSA AGAR, MODEL: REF 43 841
K091024 · bioMerieux, Inc. · Jul 2009
MRSASELECT - EXTENDED INCUBATION
K081212 · Bio-Rad · Jun 2008
MRSASELECT
K070361 · Bio-Rad · Sep 2007
BBLCHROMAGAR MRSA
K042812 · Becton, Dickinson & CO · Nov 2004
BHI W/VANCOMYCIN AGAR
K964560 · Hardy Diagnostics · Jan 1997