Cleared Traditional

AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 (K081767) - FDA 510(k) Clearance

Class I Chemistry device.

K081767 · Amnisure International, LLC · Chemistry device
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Jan 2009
Decision
203d
Days
Class 1
Risk

K081767 is an FDA 510(k) clearance for the AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1. Classified as Immunoassay For Detection Of Amniotic Fluid Protein(s). (product code NQM), Class I - General Controls.

Submitted by Amnisure International, LLC (Cambridge, US). The FDA issued a Cleared decision on January 9, 2009 after a review of 203 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1550 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K081767 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2008
Decision Date January 09, 2009
Days to Decision 203 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
115d slower than avg
Panel avg: 88d · This submission: 203d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NQM Immunoassay For Detection Of Amniotic Fluid Protein(s).
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
Definition The Test Is For Use By Health Care Professionals To Aid In The Detection Of Fetal Membrane Rupture In Pregnant Women, When They Report Signs, Symptoms Or Complaints Suggestive Of Such Rupture.
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.