Cleared Traditional

K111356 - ASIMANAGER - AT

K111356 is an FDA 510(k) clearance for ASIMANAGER - AT, manufactured by Arlington Scientific, Inc.. The device is a Class 1 Microbiology device with product code JQT cleared through the Traditional 510(k) pathway after a 177-day FDA review.

K111356 · Arlington Scientific, Inc. · Microbiology device
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Nov 2011
Decision
177d
Days
Class 1
Risk

K111356 is an FDA 510(k) clearance for the ASIMANAGER - AT. Classified as Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica (product code JQT), Class I - General Controls.

Submitted by Arlington Scientific, Inc. (Springville, US). The FDA issued a Cleared decision on November 9, 2011 after a review of 177 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 862.2400 - 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 Arlington Scientific, Inc. devices

FDA 510(k) Submission Details - K111356

510(k) Number K111356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2011
Decision Date November 09, 2011
Days to Decision 177 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 102d · This submission: 177d
Pathway characteristics
Predicate-based equivalence.

JQT Device Classification - Class 1, General Controls

Product Code JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2400
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQT Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica

All 12
Devices cleared under the same product code (JQT) and FDA review panel - the closest regulatory comparables to K111356.
ISOSCAN
K944185 · Isolab, Inc. · Nov 1994
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TARGET READER
K885254 · V-Tech, Inc. · Jan 1989
ELECTROPHORESIS DATA CENTER (EDC)
K860645 · Helena Laboratories · Dec 1986
ICON READER
K862956 · Hybritech, Inc. · Aug 1986
CORNING 780 FLUOROMETER/DENSITOMETER
K850617 · Corning Medical & Scientific · Mar 1985