Cleared Traditional

K831249 - PRO QUANTUM

K831249 is an FDA 510(k) clearance for PRO QUANTUM, manufactured by Abbott Laboratories. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K831249 · Abbott Laboratories · Chemistry device
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Jul 1983
Decision
101d
Days
Class 1
Risk

K831249 is an FDA 510(k) clearance for the PRO QUANTUM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 28, 1983 after a review of 101 days - within the typical 510(k) review window.

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 Abbott Laboratories devices

FDA 510(k) Submission Details - K831249

510(k) Number K831249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 1983
Decision Date July 28, 1983
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
13d slower than avg
Panel avg: 88d · This submission: 101d
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 67
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K831249.
MICROLAB M DILUTER/DISPENSER
K833959 · Syva Co. · Jan 1984
IL MODEL 840 MICROPROCESSOR LOADER
K833505 · Instrumentation Laboratory CO · Jan 1984
ACCU-PREP PROGRAMMABLE AUTO-DILUTER
K832809 · Beckman Instruments, Inc. · Oct 1983
QST TM SAMPLE PROCESSOR
K831273 · Syva Co. · Jun 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · Micromedic Systems · Mar 1983
MULTIWASH
K813426 · Flow Laboratories, Inc. · Dec 1981