Cleared Traditional

K822809 - AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC

K822809 is the FDA 510(k) clearance for AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC by General Diagnostics. It is a Class 2 Microbiology device (product code JTN) cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K822809 · General Diagnostics · Microbiology device
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Nov 1982
Decision
63d
Days
Class 2
Risk

K822809 is an FDA 510(k) clearance for the AZLOCILLIN 75 MCG SUSCEPTIBILITY DISC. Classified as Susceptibility Test Discs, Antimicrobial (product code JTN), Class II - Special Controls.

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on November 22, 1982 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.1620 - 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 General Diagnostics devices

Submission Details

510(k) Number K822809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 1982
Decision Date November 22, 1982
Days to Decision 63 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
39d faster than avg
Panel avg: 102d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JTN Susceptibility Test Discs, Antimicrobial
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.1620
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 - JTN Susceptibility Test Discs, Antimicrobial

All 292
Devices cleared under the same product code (JTN) and FDA review panel - the closest regulatory comparables to K822809.
NETILMICIN 30 MCG ANTIMICROBIAL DISK
K830731 · General Diagnostics · Apr 1983
NETILMICIN 30 MCG SENSI DISC
K830732 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1983
AZLOCILLIN 75MCG SENSI-DISC
K823800 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1983
TICARCILLIN 75MCG. SENSI-DISC
K822832 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1982
CEFOPERAZONE 75MCG. ANTIMICROBIAL DISK
K821229 · General Diagnostics · Jun 1982
CEFOPERAZONE 75MCG SENSIT- DISCS
K821262 · Difco Laboratories, Inc. · Jun 1982