Cleared Traditional

K920225 - AUTOSCEPTOR IDENTIFICATION SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K920225 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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May 1992
Decision
126d
Days
Class 1
Risk

K920225 is an FDA 510(k) clearance for the AUTOSCEPTOR IDENTIFICATION SYSTEM. Classified as Instrument For Auto Reader Of Overnight Microorganism Identification System (product code LRH), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on May 22, 1992 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K920225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1992
Decision Date May 22, 1992
Days to Decision 126 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 102d · This submission: 126d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LRH Instrument For Auto Reader Of Overnight Microorganism Identification System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.