Cleared Traditional

K003668 - AUTODELFIA NEONATAL IRT KIT, MODEL B005-112

K003668 is an FDA 510(k) clearance for AUTODELFIA NEONATAL IRT KIT, manufactured by Wallac OY. The device is a Class 2 Chemistry device with product code CGZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K003668 · Wallac OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
76d
Days
Class 2
Risk

K003668 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL IRT KIT, MODEL B005-112. Classified as Electrode, Ion-specific, Chloride (product code CGZ), Class II - Special Controls.

Submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on February 12, 2001 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1170 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wallac OY devices

FDA 510(k) Submission Details - K003668

510(k) Number K003668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2000
Decision Date February 12, 2001
Days to Decision 76 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
12d faster than avg
Panel avg: 88d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CGZ Device Classification - Class 2, Special Controls

Product Code CGZ Electrode, Ion-specific, Chloride
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1170
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CGZ Electrode, Ion-specific, Chloride

All 34
Devices cleared under the same product code (CGZ) and FDA review panel - the closest regulatory comparables to K003668.
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