Cleared Traditional

K923917 - ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY (FDA 510(k) Clearance)

Class I Chemistry device.

K923917 · Nuclear Diagnostics, Inc. · Chemistry device
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Feb 1994
Decision
569d
Days
Class 1
Risk

K923917 is an FDA 510(k) clearance for the ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY. Classified as Lipase-esterase, Enzymatic, Photometric, Lipase (product code CHI), Class I - General Controls.

Submitted by Nuclear Diagnostics, Inc. (Northbrook, US). The FDA issued a Cleared decision on February 25, 1994 after a review of 569 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1465 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Nuclear Diagnostics, Inc. devices

Submission Details

510(k) Number K923917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1992
Decision Date February 25, 1994
Days to Decision 569 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
481d slower than avg
Panel avg: 88d · This submission: 569d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CHI Lipase-esterase, Enzymatic, Photometric, Lipase
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1465
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.