Cleared Traditional

K061886 - ACTIM PROM AND CONTROLS

K061886 is an FDA 510(k) clearance for ACTIM PROM AND CONTROLS, manufactured by Medix Biochemica. The device is a Class 1 Chemistry device with product code OAM cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K061886 · Medix Biochemica · Chemistry device
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Jan 2007
Decision
206d
Days
Class 1
Risk

K061886 is an FDA 510(k) clearance for the ACTIM PROM AND CONTROLS. Classified as Immunoassay, Insulin-like Growth Factor Binding Protein-1 (product code OAM), Class I - General Controls.

Submitted by Medix Biochemica (North Attleboro, US). The FDA issued a Cleared decision on January 25, 2007 after a review of 206 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.

View all Medix Biochemica devices

FDA 510(k) Submission Details - K061886

510(k) Number K061886 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2006
Decision Date January 25, 2007
Days to Decision 206 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
118d slower than avg
Panel avg: 88d · This submission: 206d
Pathway characteristics
Predicate-based equivalence.

OAM Device Classification - Class 1, General Controls

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.