Cleared Traditional

K964236 - (MODIFIED) ETEST PACKAGE INSERT

K964236 is the FDA 510(k) clearance for (MODIFIED) ETEST PACKAGE INSERT by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K964236 · Ab Biodisk · Microbiology device
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May 1997
Decision
195d
Days
Class 2
Risk

K964236 is an FDA 510(k) clearance for the (MODIFIED) ETEST PACKAGE INSERT. 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 195 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 Ab Biodisk devices

Submission Details

510(k) Number K964236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1996
Decision Date May 01, 1997
Days to Decision 195 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
93d slower than avg
Panel avg: 102d · This submission: 195d
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 K964236.
ETEST FOR LEVOFLOXACIN
K971697 · Ab Biodisk · Jul 1997
ETEST FOR CEFTAZIDIME
K971694 · Ab Biodisk · Jun 1997
DRIED GRAM-NEGATIVE MIC/COMBO PANELS
K971376 · Dade Microscan, Inc. · May 1997
AMIKACIN
K970210 · Ab Biodisk · May 1997
ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE
K970473 · Ab Biodisk · May 1997
ETEST SPARFLOXACIN
K970820 · Ab Biodisk · Apr 1997