Cleared Traditional

K062534 - ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE

K062534 is an FDA 510(k) clearance for ENZYME IMMUNOASSAY FOR THE DETECTION OF..., manufactured by Drg Intl., Inc.. The device is a Class 1 Chemistry device with product code JLX cleared through the Traditional 510(k) pathway after a 518-day FDA review.

K062534 · Drg Intl., Inc. · Chemistry device
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Jan 2008
Decision
518d
Days
Class 1
Risk

K062534 is an FDA 510(k) clearance for the ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Drg Intl., Inc. (East Stroudsburg, US). The FDA issued a Cleared decision on January 29, 2008 after a review of 518 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Drg Intl., Inc. devices

FDA 510(k) Submission Details - K062534

510(k) Number K062534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2006
Decision Date January 29, 2008
Days to Decision 518 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
430d slower than avg
Panel avg: 88d · This submission: 518d
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 11
Devices cleared under the same product code (JLX) and FDA review panel - the closest regulatory comparables to K062534.
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