Cleared Traditional

K865062 - ALADIN (TM)

K865062 is an FDA 510(k) clearance for ALADIN (TM), manufactured by Analytical Products, Inc.. The device is a Class 2 Microbiology device with product code LRG cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K865062 · Analytical Products, Inc. · Microbiology device
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Mar 1987
Decision
91d
Days
Class 2
Risk

K865062 is an FDA 510(k) clearance for the ALADIN (TM). Classified as Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems (product code LRG), Class II - Special Controls.

Submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on March 25, 1987 after a review of 91 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 Analytical Products, Inc. devices

FDA 510(k) Submission Details - K865062

510(k) Number K865062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1986
Decision Date March 25, 1987
Days to Decision 91 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
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRG Device Classification - Class 2, Special Controls

Product Code LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. 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 - LRG Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

All 39
Devices cleared under the same product code (LRG) and FDA review panel - the closest regulatory comparables to K865062.
AUTOSCEPTOR-GRAM-POSITIVE MIC PANEL READING
K900821 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1990
AUTOSCEPTOR
K896447 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jan 1990
SCEPTORPETTE SYSTEM
K883907 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988