Cleared Traditional

CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM (K950186) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K950186 · Miles, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 1995
Decision
55d
Days
Class 2
Risk

K950186 is an FDA 510(k) clearance for the CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEM. Classified as U.v. Method, Cpk Isoenzymes (product code JHW), Class II - Special Controls.

Submitted by Miles, Inc. (Tarrytown, US). The FDA issued a Cleared decision on March 13, 1995 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 Miles, Inc. devices

Submission Details

510(k) Number K950186 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 1995
Decision Date March 13, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 88d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHW U.v. Method, Cpk Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHW U.v. Method, Cpk Isoenzymes

All 26
Devices cleared under the same product code (JHW) and FDA review panel - the closest regulatory comparables to K950186.
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K162526 · Roche Diagnostics · May 2017
ROCHE DIAGNOSTICS CK-MB
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ELECSYS CK-MB
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AXSYM CK-MB
K935924 · Abbott Laboratories · Jun 1994
CARDIO REP CK ISOENZYME KIT - 3310
K931050 · Helena Laboratories · Apr 1993
A-GENT CK-MB
K782015 · Abbott Laboratories · Feb 1979