Cleared Traditional

K870074 - GRAM NEGATIVE AND GRAM POSITIVE MIC/COM...

K870074 is an FDA 510(k) clearance for GRAM NEGATIVE AND GRAM POSITIVE MIC/COM..., manufactured by Microscan Div. Baxter Healthcare Corp.. The device is a Class 2 Microbiology device with product code JWY cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K870074 · Microscan Div. Baxter Healthcare Corp. · Microbiology device
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Apr 1987
Decision
96d
Days
Class 2
Risk

K870074 is an FDA 510(k) clearance for the GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on April 14, 1987 after a review of 96 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 Microscan Div. Baxter Healthcare Corp. devices

FDA 510(k) Submission Details - K870074

510(k) Number K870074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 08, 1987
Decision Date April 14, 1987
Days to Decision 96 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 102d · This submission: 96d
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 367
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K870074.
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC
K874466 · Analytical Products, Inc. · Dec 1987
NEW ANTIMICRO. AGENTS:AUGMENTIN,AZTREONAM,CIPROFLO
K874426 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1987
SENSIR SYSTEM
K870719 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1987
API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC
K870663 · Analytical Products, Inc. · Mar 1987
API UNISCEPT (TM) KB
K864891 · Analytical Products, Inc. · Feb 1987
REVISED RESISTANT 5 MIC PANEL
K864493 · Pasco Laboratories, Inc. · Feb 1987