Cleared Traditional

K210757 - ETEST Fosfomycin (FO) (0.032-512 µg/mL)

K210757 is an FDA 510(k) clearance for ETEST Fosfomycin (FO) (0.032-512 µg/mL), manufactured by Biomerieux S.A.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K210757 · Biomerieux S.A. · Microbiology device
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Nov 2021
Decision
242d
Days
Class 2
Risk

K210757 is an FDA 510(k) clearance for the ETEST Fosfomycin (FO) (0.032-512 µg/mL). Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Biomerieux S.A. (Marcy L'Etoile, FR). The FDA issued a Cleared decision on November 12, 2021 after a review of 242 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 Biomerieux S.A. devices

FDA 510(k) Submission Details - K210757

510(k) Number K210757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2021
Decision Date November 12, 2021
Days to Decision 242 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
140d slower than avg
Panel avg: 102d · This submission: 242d
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
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