Cleared Traditional

K202612 - Sensititre 20-24 hour Haemophilus influ...

K202612 is an FDA 510(k) clearance for Sensititre 20-24 hour Haemophilus influ..., 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 317-day FDA review.

K202612 · Thermo Fisher Scientific · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
317d
Days
Class 2
Risk

K202612 is an FDA 510(k) clearance for the Sensititre 20-24 hour Haemophilus influenzae /Streptococcus pneumoniae MIC or.... 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 July 23, 2021 after a review of 317 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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

FDA 510(k) Submission Details - K202612

510(k) Number K202612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2020
Decision Date July 23, 2021
Days to Decision 317 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
215d slower than avg
Panel avg: 102d · This submission: 317d
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 K202612.
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 ug/ml
K203741 · Thermo Fisher Scientific · Dec 2021
ETEST Fosfomycin (FO) (0.032-512 µg/mL)
K210757 · Biomerieux S.A. · Nov 2021
MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL
K211672 · Liofilchem S. R. L. · Oct 2021
MicroScan MICroSTREP plus Panels with Tetracycline (0.06-16 µg/mL)
K202423 · Beckman Coulter, Inc. · May 2021
ETEST Plazomicin (PLZ) (0.016-256 µg/mL)
K200512 · Biom?rieux SA · May 2020
MTS Lefamulin 0.016- 256 µg/mL
K200308 · Liofilchem S. R. 1. · Apr 2020