Cleared Traditional

CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER (K946387) - FDA 510(k) Clearance

Class I Chemistry device.

K946387 · Capintec, Inc. · Chemistry device
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Mar 1995
Decision
125d
Days
Class 1
Risk

K946387 is an FDA 510(k) clearance for the CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER. Classified as Counter (beta, Gamma) For Clinical Use (product code JJJ), Class I - General Controls.

Submitted by Capintec, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 30, 1995 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2320 - 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 Capintec, Inc. devices

Submission Details

510(k) Number K946387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1994
Decision Date March 30, 1995
Days to Decision 125 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 88d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJJ Counter (beta, Gamma) For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2320
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.