Cleared Traditional

CPK ISOENZYME SUBSTRATE (K790309) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K790309 · Electrophoresis Corp. · Hematology device
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Apr 1979
Decision
50d
Days
Class 2
Risk

K790309 is an FDA 510(k) clearance for the CPK ISOENZYME SUBSTRATE. Classified as Colorimetric Method, Cpk Or Isoenzymes (product code JHY), Class II - Special Controls.

Submitted by Electrophoresis Corp. (Mchenry, US). The FDA issued a Cleared decision on April 4, 1979 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1215 - the FDA hematology device 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. devices

Submission Details

510(k) Number K790309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 1979
Decision Date April 04, 1979
Days to Decision 50 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 113d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHY Colorimetric Method, Cpk Or Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1215
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - JHY Colorimetric Method, Cpk Or Isoenzymes

All 39
Devices cleared under the same product code (JHY) and FDA review panel - the closest regulatory comparables to K790309.
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