Cleared Traditional

K100682 - GSP NEONATAL 17A-OH-PROGESTERONE KIT MO...

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

K100682 · Wallac OY · Chemistry device
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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

Submission Details

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
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 88d · This submission: 135d
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.

Regulatory Peers - JLX Radioimmunoassay, 17-hydroxyprogesterone

Devices cleared under the same product code (JLX) and FDA review panel - the closest regulatory comparables to K100682.
BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST
K973350 · Bio-Rad · Feb 1998
DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000)
K943148 · Diagnostic Systems Laboratories, Inc. · Nov 1994
DSL 17A-OH PROGERSTERONE (DSL #6800)
K894265 · Diagnostic Systems Laboratories, Inc. · Sep 1989
COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT
K874782 · Diagnostic Products Corp. · Feb 1988
COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT
K860335 · Diagnostic Products Corp. · Apr 1986