Cleared Traditional

MOXALACTAM (K822866) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K822866 · Lilly Research Laboratories · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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

Devices cleared under the same product code (JTT) and FDA review panel - the closest regulatory comparables to K822866.
BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST
K895362 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1989
IMIPENEM 10 MCG SENSI-DISC,CAT. # 31644/31645
K855106 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1986
ANTITUBERCULOUS DRUGS (SIRE)
K822329 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982