Cleared Traditional

AZLIN AZLOCILIN SODIUM-DIAG. REAGENT (K830758) - FDA 510(k) Clearance

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

K830758 · Miles Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1983
Decision
76d
Days
Class 2
Risk

K830758 is an FDA 510(k) clearance for the AZLIN AZLOCILIN SODIUM-DIAG. REAGENT. Classified as Susceptibility Test Powders, Antimicrobial (product code JTT), Class II - Special Controls.

Submitted by Miles Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 25, 1983 after a review of 76 days - a notably fast clearance cycle.

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: 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 Miles Laboratories, Inc. devices

Submission Details

510(k) Number K830758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 1983
Decision Date May 25, 1983
Days to Decision 76 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 102d · This submission: 76d
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

All 13
Devices cleared under the same product code (JTT) and FDA review panel - the closest regulatory comparables to K830758.
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