Cleared Traditional

K822866 - MOXALACTAM

K822866 is an FDA 510(k) clearance for MOXALACTAM, manufactured by Lilly Research Laboratories. The device is a Class 2 Microbiology device with product code JTT cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K822866 · Lilly Research Laboratories · Microbiology device
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Dec 1982
Decision
92d
Days
Class 2
Risk

K822866 is an FDA 510(k) clearance for the MOXALACTAM. Classified as Susceptibility Test Powders, Antimicrobial (product code JTT), Class II - Special Controls.

Submitted by Lilly Research Laboratories (Walker, US). The FDA issued a Cleared decision on December 28, 1982 after a review of 92 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 Lilly Research Laboratories devices

FDA 510(k) Submission Details - K822866

510(k) Number K822866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1982
Decision Date December 28, 1982
Days to Decision 92 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 102d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JTT Device Classification - Class 2, Special Controls

Product Code JTT Susceptibility Test Powders, Antimicrobial
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 - JTT Susceptibility Test Powders, Antimicrobial

All 8
Devices cleared under the same product code (JTT) and FDA review panel - the closest regulatory comparables to K822866.
IMIPENEM 10 MCG SENSITIVITY DISCS
K855207 · Difco Laboratories, Inc. · Mar 1986
GEN DIAGNOSTICS' IMIPENEM 10 MCG SUSCEPTIBITY DISK
K860031 · Organon Teknika Corp. · Mar 1986
AZLIN AZLOCILIN SODIUM-DIAG. REAGENT
K830758 · Miles Laboratories, Inc. · May 1983
ANTITUBERCULOUS DRUGS (SIRE)
K822329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982