Cleared Traditional

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

K950186 is an FDA 510(k) clearance for CK-MB METHOD FOR THE TECHNICON IMMUNO 1..., manufactured by Miles, Inc.. The device is a Class 2 Chemistry device with product code JHW cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K950186 · Miles, Inc. · Chemistry device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K950186

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.

JHW Device Classification - Class 2, Special Controls

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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