Cleared Traditional

K791299 - CPK ISOENZYME CONTROL

K791299 is the FDA 510(k) clearance for CPK ISOENZYME CONTROL by Electrophoresis Corp. of America. It is a Class 1 Chemistry device (product code JJT) cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K791299 · Electrophoresis Corp. of America · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1979
Decision
31d
Days
Class 1
Risk

K791299 is an FDA 510(k) clearance for the CPK ISOENZYME CONTROL. Classified as Enzyme Controls (assayed And Unassayed) (product code JJT), Class I - General Controls.

Submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 16, 1979 after a review of 31 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 Electrophoresis Corp. of America devices

Submission Details

510(k) Number K791299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1979
Decision Date August 16, 1979
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 88d · This submission: 31d
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 61
Devices cleared under the same product code (JJT) and FDA review panel - the closest regulatory comparables to K791299.
DUPONT 'ACA' CREATINE KINASE VERIFIERS
K803305 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1981
CK ISOENZYME ELECTROPHORESIS CONTROL-I.D
K800604 · Beckman Instruments, Inc. · Apr 1980
QUANTAFFIRM CPK ISO ENZYME SERUM (HUMAN)
K791723 · Organon, Inc. · Oct 1979
P.A.P. RIA CONTROL SERUM PACK
K790985 · Mallinckrodt Critical Care · Jul 1979
DELTA TEST AMYLASE/LIPASE CONTS. I,II
K781100 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1978
ISOZYME - ID CPK MARKER
K780801 · Dade, Baxter Travenol Diagnostics, Inc. · Jun 1978