Cleared Abbreviated

K060452 - ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH

K060452 is an FDA 510(k) clearance for ACCUWELL 17-ALPHA-HYDROXYPROESTERONE EN..., manufactured by Neo-Genesis. The device is a Class 1 Chemistry device with product code JLX cleared through the Abbreviated 510(k) pathway after a 385-day FDA review.

K060452 · Neo-Genesis · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2007
Decision
385d
Days
Class 1
Risk

K060452 is an FDA 510(k) clearance for the ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Neo-Genesis (Portland, US). The FDA issued a Cleared decision on March 13, 2007 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1395 - the FDA in vitro diagnostics and chemistry framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Neo-Genesis devices

FDA 510(k) Submission Details - K060452

510(k) Number K060452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 2006
Decision Date March 13, 2007
Days to Decision 385 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
297d slower than avg
Panel avg: 88d · This submission: 385d
Pathway characteristics
Standards-based clearance path.

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 11
Devices cleared under the same product code (JLX) and FDA review panel - the closest regulatory comparables to K060452.
GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U
K100682 · Wallac OY · Jul 2010
AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT
K081922 · Wallac OY · Apr 2009
MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT
K050960 · Wallac OY · Jul 2005
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