Cleared Traditional

K940390 - IMPACT

K940390 is an FDA 510(k) clearance for IMPACT, manufactured by Matrix Technologies Corp.. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K940390 · Matrix Technologies Corp. · Chemistry device
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May 1994
Decision
97d
Days
Class 1
Risk

K940390 is an FDA 510(k) clearance for the IMPACT. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Matrix Technologies Corp. (Lowell, US). The FDA issued a Cleared decision on May 3, 1994 after a review of 97 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.

FDA 510(k) Submission Details - K940390

510(k) Number K940390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1994
Decision Date May 03, 1994
Days to Decision 97 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 89d · This submission: 97d
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 139
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K940390.
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K933088 · Rosys, Inc. · Feb 1994
K940390 · IMPACT
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