Cleared Traditional

ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE (K062534) - FDA 510(k) Clearance

Class I Chemistry device.

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

Submission Details

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.

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.