Cleared Traditional

K894189 - SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID

K894189 is an FDA 510(k) clearance for SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/C..., manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K894189 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Microbiology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K894189

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.

JWY Device Classification - Class 2, Special Controls

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 410
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K894189.
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K896965 · Alamar Biosciences Laboratory, Inc. · Jan 1990
API UNISCEPT KB
K895796 · Analytical Products, Inc. · Nov 1989
ANTIMICROBIAL SUSCEPTIBILITY TEST PANEL
K894514 · Alamar Biosciences Laboratory, Inc. · Nov 1989
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
MODIFICATION MIC/API UNISCEPT(R)
K884509 · Analytical Products, Inc. · Nov 1988