Cleared Traditional

K790916 - CK-NUC REAGENT (FDA 510(k) Clearance)

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

K790916 · Smithkline Diagnostics, Inc. · Chemistry device
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Jun 1979
Decision
39d
Days
Class 2
Risk

K790916 is an FDA 510(k) clearance for the CK-NUC REAGENT. Classified as Differential Rate Kinetic Method, Cpk Or Isoenzymes (product code JHS), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1979 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - 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 Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K790916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1979
Decision Date June 22, 1979
Days to Decision 39 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 88d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHS Differential Rate Kinetic 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 Chemistry devices follow this clearance model.