Cleared Traditional

AMNIOTEST(TM) (K914419) - FDA 510(k) Clearance

Class I Chemistry device.

K914419 · Pro-Lab, Inc. · Chemistry device
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Sep 1993
Decision
699d
Days
Class 1
Risk

K914419 is an FDA 510(k) clearance for the AMNIOTEST(TM). Classified as Sampler, Amniotic Fluid (amniocentesis Tray) (product code HIO), Class I - General Controls.

Submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on September 1, 1993 after a review of 699 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 884.1550 - 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.

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Submission Details

510(k) Number K914419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1991
Decision Date September 01, 1993
Days to Decision 699 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
611d slower than avg
Panel avg: 88d · This submission: 699d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HIO Sampler, Amniotic Fluid (amniocentesis Tray)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 884.1550
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.