Cleared Traditional

K946265 - FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3

K946265 is an FDA 510(k) clearance for FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3, manufactured by Clinical Controls, Inc.. The device is a Class 2 Hematology device with product code GIL cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K946265 · Clinical Controls, Inc. · Hematology device
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Aug 1995
Decision
244d
Days
Class 2
Risk

K946265 is an FDA 510(k) clearance for the FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3. Classified as Plasma, Fibrinogen Control (product code GIL), Class II - Special Controls.

Submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on August 24, 1995 after a review of 244 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7340 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Clinical Controls, Inc. devices

FDA 510(k) Submission Details - K946265

510(k) Number K946265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1994
Decision Date August 24, 1995
Days to Decision 244 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
131d slower than avg
Panel avg: 113d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GIL Device Classification - Class 2, Special Controls

Product Code GIL Plasma, Fibrinogen Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7340
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GIL Plasma, Fibrinogen Control

All 7
Devices cleared under the same product code (GIL) and FDA review panel - the closest regulatory comparables to K946265.
N/T PROTEIN CONTROL PY
K962407 · Behring Diagnostics, Inc. · Jul 1996
FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3
K946193 · More Diagnostics · Aug 1995
PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2
K935598 · Clinical Controls, Inc. · May 1995
N/T PROTEIN CONTROL PY
K951012 · Behring Diagnostics, Inc. · Apr 1995
LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2
K934741 · Clinical Controls, Inc. · Sep 1994
FIBRINOGEN CONTROL
K915462 · Sigma Diagnostics, Inc. · Mar 1992