Cleared Traditional

17-HYDROXYPROGESTERONE TEST SET (K771729) - FDA 510(k) Clearance

Class I Chemistry device.

K771729 · Wien Laboratories, Inc. · Chemistry device
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Oct 1977
Decision
37d
Days
Class 1
Risk

K771729 is an FDA 510(k) clearance for the 17-HYDROXYPROGESTERONE TEST SET. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Wien Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 21, 1977 after a review of 37 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 Wien Laboratories, Inc. devices

Submission Details

510(k) Number K771729 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1977
Decision Date October 21, 1977
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 88d · This submission: 37d
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.