Cleared Traditional

K071649 - NEONATAL TOTAL GALACTOSE KIT (FDA 510(k) Clearance)

Also includes:
NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

Class I Chemistry device.

K071649 · Wallac OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
416d
Days
Class 1
Risk

K071649 is an FDA 510(k) clearance for the NEONATAL TOTAL GALACTOSE KIT. Classified as Enzymatic Methods, Galactose (product code JIA), Class I - General Controls.

Submitted by Wallac OY (Waltham, US). The FDA issued a Cleared decision on August 7, 2008 after a review of 416 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 Wallac OY devices

Submission Details

510(k) Number K071649 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 2007
Decision Date August 07, 2008
Days to Decision 416 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
328d slower than avg
Panel avg: 88d · This submission: 416d
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.