Cleared Traditional

K881194 - RIA-QUICK

K881194 is an FDA 510(k) clearance for RIA-QUICK, manufactured by Quantitative Technologies, Inc.. The device is a Class 1 Chemistry device with product code JQP cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K881194 · Quantitative Technologies, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Jun 1988
Decision
72d
Days
Class 1
Risk

K881194 is an FDA 510(k) clearance for the RIA-QUICK. Classified as Calculator/data Processing Module, For Clinical Use (product code JQP), Class I - General Controls.

Submitted by Quantitative Technologies, Inc. (Westboro, US). The FDA issued a Cleared decision on June 1, 1988 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2100 - 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 Quantitative Technologies, Inc. devices

FDA 510(k) Submission Details - K881194

510(k) Number K881194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1988
Decision Date June 01, 1988
Days to Decision 72 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 88d · This submission: 72d
Pathway characteristics
Predicate-based equivalence.

JQP Device Classification - Class 1, General Controls

Product Code JQP Calculator/data Processing Module, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2100
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 - JQP Calculator/data Processing Module, For Clinical Use

All 56
Devices cleared under the same product code (JQP) and FDA review panel - the closest regulatory comparables to K881194.
MODIFIED MODEL 570 CLINICAL CHEMISTRY ANALYZER
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710 PLUS
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K861844 · Miles Laboratories, Inc. · Aug 1986