Cleared Traditional

K930889 - ROCHE CARDIOTROL-CK

K930889 is the FDA 510(k) clearance for ROCHE CARDIOTROL-CK by Roche Diagnostic Systems, Inc.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K930889 · Roche Diagnostic Systems, Inc. · Chemistry device
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Jul 1993
Decision
134d
Days
Class 1
Risk

K930889 is an FDA 510(k) clearance for the ROCHE CARDIOTROL-CK. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Roche Diagnostic Systems, Inc. (Branchburg, US). The FDA issued a Cleared decision on July 6, 1993 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K930889 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 1993
Decision Date July 06, 1993
Days to Decision 134 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
46d slower than avg
Panel avg: 88d · This submission: 134d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJT Enzyme Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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 - JJT Enzyme Controls (assayed And Unassayed)

All 49
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