Cleared Traditional

K123986 - ACTIM PROM (FDA 510(k) Clearance)

Class I Chemistry device.

K123986 · Alere Scarborough, Inc. · Chemistry device
Jan 2014
Decision
379d
Days
Class 1
Risk

K123986 is an FDA 510(k) clearance for the ACTIM PROM. Classified as Immunoassay, Insulin-like Growth Factor Binding Protein-1 (product code OAM), Class I - General Controls.

Submitted by Alere Scarborough, Inc. (Scarborough, US). The FDA issued a Cleared decision on January 9, 2014 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. 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.

Submission Details

510(k) Number K123986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2012
Decision Date January 09, 2014
Days to Decision 379 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 234d · This submission: 379d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OAM Immunoassay, Insulin-like Growth Factor Binding Protein-1
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1550
Definition The Device Is A Qualitative Immunochromatographic Test For The Detection Of Amniotic Fluid In Cervicovaginal Secretions. The Test Is Intended For Professional Use To Help Diagnose The Rupture Of Fetal Membranes In Pregnant Women.
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.