Cleared Traditional

K121101 - SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K121101 · Astoria-Pacific, Inc. · Chemistry device
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Jun 2013
Decision
435d
Days
Class 1
Risk

K121101 is an FDA 510(k) clearance for the SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT. Classified as Enzymatic Methods, Galactose (product code JIA), Class I - General Controls.

Submitted by Astoria-Pacific, Inc. (Clackamas, US). The FDA issued a Cleared decision on June 20, 2013 after a review of 435 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1310 - 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 K121101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2012
Decision Date June 20, 2013
Days to Decision 435 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
347d slower than avg
Panel avg: 88d · This submission: 435d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JIA Enzymatic Methods, Galactose
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1310
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.