Cleared Special

K050960 - MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

K050960 is an FDA 510(k) clearance for MODIFICATION TO: AUTODELFIA NEONATAL 17..., manufactured by Wallac OY. The device is a Class 1 Chemistry device with product code JLX cleared through the Special 510(k) pathway after a 84-day FDA review.

K050960 · Wallac OY · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
84d
Days
Class 1
Risk

K050960 is an FDA 510(k) clearance for the MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L 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 July 11, 2005 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1395 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K050960

510(k) Number K050960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date July 11, 2005
Days to Decision 84 days
Submission Type Special
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
5d faster than avg
Panel avg: 89d · This submission: 84d
Pathway characteristics
Modification to existing cleared device.

JLX Device Classification - Class 1, General Controls

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.

Regulatory Peers - JLX Radioimmunoassay, 17-hydroxyprogesterone

All 18
Devices cleared under the same product code (JLX) and FDA review panel - the closest regulatory comparables to K050960.
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K081922 · Wallac OY · Apr 2009
ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE
K062534 · Drg Intl., Inc. · Jan 2008
ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH
K060452 · Neo-Genesis · Mar 2007
DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042424 · Wallac OY · Sep 2004
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K042425 · Wallac OY · Sep 2004
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K973350 · Bio-Rad · Feb 1998
K050960 · MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
Download PDF FDA Summary Wallac OY