Cleared Traditional

K971697 - ETEST FOR LEVOFLOXACIN

K971697 is the FDA 510(k) clearance for ETEST FOR LEVOFLOXACIN by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K971697 · Ab Biodisk · Microbiology device
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Jul 1997
Decision
67d
Days
Class 2
Risk

K971697 is an FDA 510(k) clearance for the ETEST FOR LEVOFLOXACIN. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Ab Biodisk (Solna, SE). The FDA issued a Cleared decision on July 14, 1997 after a review of 67 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ab Biodisk devices

Submission Details

510(k) Number K971697 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1997
Decision Date July 14, 1997
Days to Decision 67 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
35d faster than avg
Panel avg: 102d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 360
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K971697.
PASCO MIC AND MIC/ID PANELS
K972567 · Pasco Laboratories, Inc. · Aug 1997
PASCO MIC AND MIC/ID PANELS
K971951 · Pasco Laboratories, Inc. · Aug 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K972180 · Dade Microscan, Inc. · Aug 1997
ETEST FOR CEFTAZIDIME
K971694 · Ab Biodisk · Jun 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K971376 · Dade Microscan, Inc. · May 1997
(MODIFIED) ETEST PACKAGE INSERT
K964236 · Ab Biodisk · May 1997