Cleared Traditional

K081922 - AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT (FDA 510(k) Clearance)

Class I Chemistry device.

K081922 · Wallac OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2009
Decision
283d
Days
Class 1
Risk

K081922 is an FDA 510(k) clearance for the AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Wallac OY (Turku, FI). The FDA issued a Cleared decision on April 16, 2009 after a review of 283 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1395 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Wallac OY devices

Submission Details

510(k) Number K081922 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2008
Decision Date April 16, 2009
Days to Decision 283 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
195d slower than avg
Panel avg: 88d · This submission: 283d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JLX Radioimmunoassay, 17-hydroxyprogesterone
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1395
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.