Cleared Traditional

K912897 - SCEPTOR IDENTIFICATION SYSTEM (FDA 510(k) Clearance)

Class I Microbiology device.

K912897 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Oct 1991
Decision
119d
Days
Class 1
Risk

K912897 is an FDA 510(k) clearance for the SCEPTOR IDENTIFICATION SYSTEM. Classified as Gram Negative Identification Panel (product code LQM), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 28, 1991 after a review of 119 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.

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Submission Details

510(k) Number K912897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1991
Decision Date October 28, 1991
Days to Decision 119 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
17d slower than avg
Panel avg: 102d · This submission: 119d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LQM Gram Negative Identification Panel
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.