Cleared Traditional

ACCUFLEX (K834590) - FDA 510(k) Clearance

Class I Chemistry device.

K834590 · Micromedic Systems · Chemistry device
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Mar 1984
Decision
81d
Days
Class 1
Risk

K834590 is an FDA 510(k) clearance for the ACCUFLEX. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Micromedic Systems (Walker, US). The FDA issued a Cleared decision on March 19, 1984 after a review of 81 days - a notably fast clearance 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: 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 Micromedic Systems devices

Submission Details

510(k) Number K834590 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1983
Decision Date March 19, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 88d · This submission: 81d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 27
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K834590.
DADE BLOOD GAS AMPUL INJECTOR
K852285 · American Dade · Jul 1985
SYVA IQ 190 DIGITAL PIPETTER DILUTER
K842390 · Syva Co. · Jul 1984
BEHRING ELISA PROCESSOR M
K841043 · Behring Diagnostics, Inc. · Jul 1984
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