Cleared Traditional

K854973 - V-TREND OC CPK

K854973 is the FDA 510(k) clearance for V-TREND OC CPK by V-Tech, Inc.. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K854973 · V-Tech, Inc. · Chemistry device
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Jan 1986
Decision
33d
Days
Class 1
Risk

K854973 is an FDA 510(k) clearance for the V-TREND OC CPK. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by V-Tech, Inc. (Pomona, US). The FDA issued a Cleared decision on January 13, 1986 after a review of 33 days - a notably fast clearance cycle.

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: 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 V-Tech, Inc. devices

Submission Details

510(k) Number K854973 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date January 13, 1986
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 88d · This submission: 33d
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 59
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K854973.
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
K861512 · Em Diagnostic Systems, Inc. · May 1986
ISOTRAK AMYLASE ISOENZYME CONTROL SET
K861329 · Behring Diagnostics, Inc. · Apr 1986
EMDS ENZYME VERIFIER, LEVELS I & II
K860764 · Em Diagnostic Systems, Inc. · Apr 1986
DELTA TROL I & II
K853373 · Electro-Nucleonics Laboratories, Inc. · Aug 1985
ISOCONTROL SERUM CK-MB
K850213 · Sclavo, Inc. · Mar 1985
ISOCONTROL SERUM LD-
K850211 · Sclavo, Inc. · Feb 1985