Cleared Traditional

K884510 - MODIFICATION MICRO-MIC

K884510 is the FDA 510(k) clearance for MODIFICATION MICRO-MIC by Analytical Products, Inc.. It is a Class 2 Microbiology device (product code JWY) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K884510 · Analytical Products, Inc. · Microbiology device
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Nov 1988
Decision
26d
Days
Class 2
Risk

K884510 is an FDA 510(k) clearance for the MODIFICATION MICRO-MIC. Classified as Manual Antimicrobial Susceptibility Test Systems (product code JWY), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on November 22, 1988 after a review of 26 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Analytical Products, Inc. devices

Submission Details

510(k) Number K884510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 1988
Decision Date November 22, 1988
Days to Decision 26 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 102d · This submission: 26d
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 172
Devices cleared under the same product code (JWY) and FDA review panel - the closest regulatory comparables to K884510.
SCEPTOR-NEW ANTIMICROBIAL AGENT:TICAR/CLAVU ACID
K894189 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 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
SCEPTOR GRAM-POSITIVE BREAKPOINT/ID PANEL
K883798 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
SCEPTOR GRAM-NEGATIVE BREAKPOINT/ID PANEL
K883800 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
SCEPTOR STAPHYLOCOCCUS MIC/ID PANEL #80325
K883551 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1988