Cleared Traditional

K980335 - ETEST BENZYLPENICILLIN

K980335 is the FDA 510(k) clearance for ETEST BENZYLPENICILLIN by Ab Biodisk. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K980335 · Ab Biodisk · Microbiology device
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Jun 1998
Decision
138d
Days
Class 2
Risk

K980335 is an FDA 510(k) clearance for the ETEST BENZYLPENICILLIN. 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 June 15, 1998 after a review of 138 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

Submission Details

510(k) Number K980335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 1998
Decision Date June 15, 1998
Days to Decision 138 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
36d slower than avg
Panel avg: 102d · This submission: 138d
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 K980335.
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ETEST CEFDINIR
K980877 · Ab Biodisk · Jul 1998
ETEST BENZYLPENICILLIN
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ETEST FOSFOMYCIN
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ETEST CEFOTAXIME
K981137 · Ab Biodisk · Jun 1998