Cleared Traditional

K133847 - SENSITITRE HAEMOPHILUS / STREPTOCOCCUS ...

K133847 is an FDA 510(k) clearance for SENSITITRE HAEMOPHILUS / STREPTOCOCCUS ..., manufactured by Thermo Fisher Scientific. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 226-day FDA review.

K133847 · Thermo Fisher Scientific · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2014
Decision
226d
Days
Class 2
Risk

K133847 is an FDA 510(k) clearance for the SENSITITRE HAEMOPHILUS / STREPTOCOCCUS PNEUMONIAE (HP) SUSCEPTIBILITY PLATES. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Thermo Fisher Scientific (Oakwood Village, US). The FDA issued a Cleared decision on August 1, 2014 after a review of 226 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1640 - 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

FDA 510(k) Submission Details - K133847

510(k) Number K133847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2013
Decision Date August 01, 2014
Days to Decision 226 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
124d slower than avg
Panel avg: 102d · This submission: 226d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWY Device Classification - Class 2, Special Controls

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1640
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 391
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K133847.
Sensititre Susceptibility Plates
K143381 · Thermo Fisher Scientific · Feb 2015
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
K142151 · Thermo Fisher Scientific · Dec 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141651 · Thermo Fisher Scientific · Oct 2014
SENSITITRE SUSCEPTIBILITY PLATES
K141000 · Thermo Fisher Scientific · Jul 2014
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE(HP) SUSCEPTIBILITY PLATES
K140985 · Thermo Fisher Scientific · Jun 2014
SENSITITRE 18-24 HOUR MIC SUCEPTIBILITY SYSTEM
K133773 · Thermo Fisher Scientific · Feb 2014