Cleared Traditional

K971817 - OLYMPUS CK-MB REAGENT (FDA 510(k) Clearance)

Class I Chemistry device.

K971817 · Olympus America, Inc. · Chemistry device
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Jun 1997
Decision
26d
Days
Class 1
Risk

K971817 is an FDA 510(k) clearance for the OLYMPUS CK-MB REAGENT. Classified as Atp And Creatine Kinase (enzymatic), Creatine (product code JLB), Class I - General Controls.

Submitted by Olympus America, Inc. (Melville, US). The FDA issued a Cleared decision on June 11, 1997 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1210 - 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 Olympus America, Inc. devices

Submission Details

510(k) Number K971817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1997
Decision Date June 11, 1997
Days to Decision 26 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
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLB Atp And Creatine Kinase (enzymatic), Creatine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1210
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.