Cleared Traditional

K051111 - SENTINEL UIBC LIQUID

K051111 is an FDA 510(k) clearance for SENTINEL UIBC LIQUID, manufactured by Sentinel Ch. Srl. The device is a Class 1 Chemistry device with product code JQF cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K051111 · Sentinel Ch. Srl · Chemistry device
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Nov 2005
Decision
199d
Days
Class 1
Risk

K051111 is an FDA 510(k) clearance for the SENTINEL UIBC LIQUID. Classified as Bathophenanthroline, Iron Binding Capacity (product code JQF), Class I - General Controls.

Submitted by Sentinel Ch. Srl (Milano, IT). The FDA issued a Cleared decision on November 17, 2005 after a review of 199 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1415 - 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 Sentinel Ch. Srl devices

FDA 510(k) Submission Details - K051111

510(k) Number K051111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2005
Decision Date November 17, 2005
Days to Decision 199 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d slower than avg
Panel avg: 88d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

JQF Device Classification - Class 1, General Controls

Product Code JQF Bathophenanthroline, Iron Binding Capacity
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1415
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 - JQF Bathophenanthroline, Iron Binding Capacity

Devices cleared under the same product code (JQF) and FDA review panel - the closest regulatory comparables to K051111.
WAKO L-TYPE UIBC, WAKO UIBC CALIBRATOR
K984122 · Wako Chemicals USA, Inc. · Jan 1999
WAKO(TM) UIBC
K875176 · Wako Chemicals USA, Inc. · Feb 1988
TRANSFERMETER
K863066 · J. D. Assoc. · Dec 1986
TOTAL IRON BINDING CAPACITY TEST
K830032 · Sclavo, Inc. · Jan 1983
IRON & TICB
K810086 · Bio-Analytics Laboratories, Inc. · Jan 1981
ELVI TOTAL IRON BINDING CAPACITY
K792409 · Volu Sol Medical Industries · Dec 1979