Cleared Traditional

K100682 - GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U

K100682 is an FDA 510(k) clearance for GSP NEONATAL 17A-OH-PROGESTERONE KIT MO..., manufactured by Wallac OY. The device is a Class 1 Chemistry device with product code JLX cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K100682 · Wallac OY · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2010
Decision
135d
Days
Class 1
Risk

K100682 is an FDA 510(k) clearance for the GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Wallac OY (Indianapolis, US). The FDA issued a Cleared decision on July 23, 2010 after a review of 135 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K100682

510(k) Number K100682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2010
Decision Date July 23, 2010
Days to Decision 135 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
47d slower than avg
Panel avg: 88d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

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 10
Devices cleared under the same product code (JLX) and FDA review panel - the closest regulatory comparables to K100682.
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
ACCUSCREEN 17-HYDROXYPROGESTERONE
K934178 · Neometrics, Inc. · Mar 1995