Cleared Traditional

K110605 - ROM PLUS (FDA 510(k) Clearance)

Class I Chemistry device.

K110605 · Clinical Innovations, LLC · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2011
Decision
266d
Days
Class 1
Risk

K110605 is an FDA 510(k) clearance for the ROM PLUS. Classified as Immunoassay For Detection Of Amniotic Fluid Protein(s). (product code NQM), Class I - General Controls.

Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on November 23, 2011 after a review of 266 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 K110605 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date November 23, 2011
Days to Decision 266 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
178d slower than avg
Panel avg: 88d · This submission: 266d
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.