Cleared Traditional

K121101 - SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KIT

K121101 is an FDA 510(k) clearance for SPOTCHECK NEONATAL TOTAL GALACTOSE MICR..., manufactured by Astoria-Pacific, Inc.. The device is a Class 1 Chemistry device with product code JIA cleared through the Traditional 510(k) pathway after a 435-day FDA review.

K121101 · Astoria-Pacific, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K121101

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
347d slower than avg
Panel avg: 88d · This submission: 435d
Pathway characteristics
Predicate-based equivalence.

JIA Device Classification - Class 1, General Controls

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.

Regulatory Peers - JIA Enzymatic Methods, Galactose

All 8
Devices cleared under the same product code (JIA) and FDA review panel - the closest regulatory comparables to K121101.
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