Cleared Traditional

K970210 - AMIKACIN

K970210 is an FDA 510(k) clearance for AMIKACIN, manufactured by Ab Biodisk. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K970210 · Ab Biodisk · Microbiology device
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May 1997
Decision
100d
Days
Class 2
Risk

K970210 is an FDA 510(k) clearance for the AMIKACIN. 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 May 1, 1997 after a review of 100 days - within the typical 510(k) review window.

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 Ab Biodisk devices

FDA 510(k) Submission Details - K970210

510(k) Number K970210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date May 01, 1997
Days to Decision 100 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
2d faster than avg
Panel avg: 102d · This submission: 100d
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 404
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K970210.
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K971376 · Dade Microscan, Inc. · May 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K970676 · Dade Intl., Inc. · May 1997
(MODIFIED) ETEST PACKAGE INSERT
K964236 · Ab Biodisk · May 1997
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
K970473 · Ab Biodisk · May 1997
ETEST SPARFLOXACIN
K970820 · Ab Biodisk · Apr 1997
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE MIC PLATE
K965190 · Accumed Intl., Inc. · Mar 1997