Cleared Traditional

K934178 - ACCUSCREEN 17-HYDROXYPROGESTERONE (FDA 510(k) Clearance)

Class I Chemistry device.

K934178 · Neometrics, Inc. · Chemistry device
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Mar 1995
Decision
580d
Days
Class 1
Risk

K934178 is an FDA 510(k) clearance for the ACCUSCREEN 17-HYDROXYPROGESTERONE. Classified as Radioimmunoassay, 17-hydroxyprogesterone (product code JLX), Class I - General Controls.

Submitted by Neometrics, Inc. (E. Northport, US). The FDA issued a Cleared decision on March 30, 1995 after a review of 580 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 Neometrics, Inc. devices

Submission Details

510(k) Number K934178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1993
Decision Date March 30, 1995
Days to Decision 580 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
492d slower than avg
Panel avg: 88d · This submission: 580d
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.