Cleared Traditional

K946387 - CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER

K946387 is an FDA 510(k) clearance for CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER, manufactured by Capintec, Inc.. The device is a Class 1 Chemistry device with product code JJJ cleared through the Traditional 510(k) pathway after a 125-day FDA review.

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.

FDA 510(k) Submission Details - K946387

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 89d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

JJJ Device Classification - Class 1, General Controls

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.

Regulatory Peers - JJJ Counter (beta, Gamma) For Clinical Use

All 62
Devices cleared under the same product code (JJJ) and FDA review panel - the closest regulatory comparables to K946387.
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
K962762 · Biotraces, Inc. · Aug 1996
ABBOTT VERTEX ANALYZER
K920559 · Abbott Laboratories · Mar 1992
GENESYS 6000 GAMMA COUNTER
K900087 · Laboratory Technologies, Inc. · Jul 1990
MATRIX(TM)-96
K896202 · Canberra Industries, Inc. · Jan 1990
SOURCERER
K894902 · Oakfield Instruments, Ltd. · Oct 1989
SOURCERER
K884091 · John Caunt Scientific , Ltd. · Feb 1989
K946387 · CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
Download PDF Capintec, Inc.