Cleared Traditional

K921455 - ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD (FDA 510(k) Clearance)

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

K921455 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Apr 1992
Decision
33d
Days
Class 2
Risk

K921455 is an FDA 510(k) clearance for the ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD. Classified as Electrophoretic, Lactate Dehydrogenase Isoenzymes (product code CFE), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on April 29, 1992 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1445 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K921455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1992
Decision Date April 29, 1992
Days to Decision 33 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
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. No clinical trials required.

Device Classification

Product Code CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1445
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.