Cleared Traditional

K934124 - AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM

K934124 is an FDA 510(k) clearance for AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM, manufactured by Andronic Devices, Ltd.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K934124 · Andronic Devices, Ltd. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1994
Decision
231d
Days
Class 1
Risk

K934124 is an FDA 510(k) clearance for the AUTOQUOT AUTOMATED ALIQUOTTING SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Andronic Devices, Ltd. (Richmond, B.C. Canada V6v 2j2, CA). The FDA issued a Cleared decision on April 13, 1994 after a review of 231 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Andronic Devices, Ltd. devices

FDA 510(k) Submission Details - K934124

510(k) Number K934124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1993
Decision Date April 13, 1994
Days to Decision 231 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
143d slower than avg
Panel avg: 88d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 83
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K934124.
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MAXSOFTWARE
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K921005 · Innovative Medical Systems, Inc. · Apr 1992