Cleared Traditional

K970093 - TYROSINE 50-HOUR REAGENT KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K970093 · Astoria-Pacific, Inc. · Chemistry device
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Optimized for regulatory review, auditing and printing
Mar 1998
Decision
433d
Days
Class 1
Risk

K970093 is an FDA 510(k) clearance for the TYROSINE 50-HOUR REAGENT KIT. Classified as 1-nitroso-2-naphthol (fluorometric), Free Tyrosine (product code CDR), Class I - General Controls.

Submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on March 19, 1998 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1730 - 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 Astoria-Pacific, Inc. devices

Submission Details

510(k) Number K970093 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1997
Decision Date March 19, 1998
Days to Decision 433 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
345d slower than avg
Panel avg: 88d · This submission: 433d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CDR 1-nitroso-2-naphthol (fluorometric), Free Tyrosine
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1730
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.