Cleared Traditional

SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID (K894189) - FDA 510(k) Clearance

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

K894189 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Oct 1989
Decision
116d
Days
Class 2
Risk

K894189 is an FDA 510(k) clearance for the SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on October 10, 1989 after a review of 116 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K894189 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1989
Decision Date October 10, 1989
Days to Decision 116 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 102d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWY Manual Antimicrobial Susceptibility Test Systems
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 - JWY Manual Antimicrobial Susceptibility Test Systems

All 121
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K894189.
DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH PENICILLIN
K020162 · Dade Behring, Inc. · Mar 2002
DRIED GRAM-NEGATIVE AND POSITIVE MIC/COMBO PANELS
K922458 · Baxter Healthcare Corp · Dec 1992
SCEPTOR - NEW ANTIMICROBIAL AGENT - CEFOTETAN
K896278 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K894146 · Baxter Healthcare Corp · Sep 1989
GRAM NEGATIVE AND POSITIVE MIC/COMBO PANELS
K893977 · Baxter Healthcare Corp · Aug 1989
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988