Cleared Traditional

AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1 (K030849) - FDA 510(k) Clearance

Class I Chemistry device.

K030849 · N-Dia, Inc. · Chemistry device
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Feb 2004
Decision
322d
Days
Class 1
Risk

K030849 is an FDA 510(k) clearance for the AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1. Classified as Single (specified) Analyte Controls (assayed And Unassayed) (product code JJX), Class I - General Controls.

Submitted by N-Dia, Inc. (New York, US). The FDA issued a Cleared decision on February 2, 2004 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all N-Dia, Inc. devices

Submission Details

510(k) Number K030849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2003
Decision Date February 02, 2004
Days to Decision 322 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
234d slower than avg
Panel avg: 88d · This submission: 322d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JJX Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1660
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.

Regulatory Peers - JJX Single (specified) Analyte Controls (assayed And Unassayed)

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