Cleared Traditional

17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA (K885198) - FDA 510(k) Clearance

Class I Chemistry device.

K885198 · Icn Biomedicals, Inc. · Chemistry device
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Feb 1989
Decision
69d
Days
Class 1
Risk

K885198 is an FDA 510(k) clearance for the 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Icn Biomedicals, Inc. (Carson, US). The FDA issued a Cleared decision on February 23, 1989 after a review of 69 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Icn Biomedicals, Inc. devices

Submission Details

510(k) Number K885198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1988
Decision Date February 23, 1989
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 88d · This submission: 69d
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.