Cleared Traditional

CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/ (K850907) - FDA 510(k) Clearance

Class I Chemistry device.

K850907 · Cala Diagnostics · Chemistry device
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Jun 1985
Decision
112d
Days
Class 1
Risk

K850907 is an FDA 510(k) clearance for the CK 1-3, LD 1-5 ISOENZYME CONTROL HUMAN LEVELS 1/2/. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Cala Diagnostics (Los Osos, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 112 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 Cala Diagnostics devices

Submission Details

510(k) Number K850907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1985
Decision Date June 25, 1985
Days to Decision 112 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 88d · This submission: 112d
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 96
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