Augmentin 30MCG Suscep Disk

No FDA recalls found in the data synced 6 Oct 2026.

Full name

General Diagnostics Augmentin 30mcg Suscep Disk

510(k) Number

K851228 ↗

FDA Product Code

JTN

Device Class

Class II

Regulation

21 CFR Part 866.1620

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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• What is the Augmentin 30mcg Suscep Disk used for in a clinical setting?

  The Augmentin 30mcg Suscep Disk is an antimicrobial susceptibility test disc used exclusively for in vitro microbiological testing. It helps determine whether bacteria are susceptible, intermediate, or resistant to amoxicillin-clavulanate (Augmentin) by measuring the zone of inhibition around the disc on agar plates. This aids clinicians in guiding appropriate antibiotic treatment decisions.

• Is this disc single-use or reusable, and what are the sterility requirements?

  The Augmentin 30mcg Suscep Disk is explicitly designed for single-use only and is non-sterile. Since it is intended for in vitro use in microbiology laboratories, sterility is not a requirement, and no special handling beyond standard laboratory practices is specified.

• How is the Augmentin 30mcg Suscep Disk supplied, and what regulatory pathway was followed for its clearance?

  The disc is supplied as part of a diagnostic kit for antimicrobial susceptibility testing, with no additional packaging details specified beyond its classification as a single-use, non-sterile tool. It was cleared under the Traditional 510(k) pathway (K851228) in 1985, determined to be substantially equivalent to a predicate device, and falls under FDA regulation 866.1620 for susceptibility test discs.

• What product code and regulatory classification does this device hold, and which advisory committee reviewed it?

  The Augmentin 30mcg Suscep Disk is assigned the product code JTN and is classified under Susceptibility Test Discs (Antimicrobial) in the FDA’s regulatory nomenclature. It was reviewed by the Microbiology (MI) Advisory Committee as part of its 510(k) submission process.