Cleared Traditional

K915462 - FIBRINOGEN CONTROL

K915462 is an FDA 510(k) clearance for FIBRINOGEN CONTROL, manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GIL cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K915462 · Sigma Diagnostics, Inc. · Hematology device
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Mar 1992
Decision
91d
Days
Class 2
Risk

K915462 is an FDA 510(k) clearance for the FIBRINOGEN CONTROL. Classified as Plasma, Fibrinogen Control (product code GIL), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 4, 1992 after a review of 91 days - within the typical 510(k) review window.

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 Sigma Diagnostics, Inc. devices

FDA 510(k) Submission Details - K915462

510(k) Number K915462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1991
Decision Date March 04, 1992
Days to Decision 91 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
22d faster than avg
Panel avg: 113d · This submission: 91d
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 K915462.
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
GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL
K833352 · Warner-Lambert Co. · Nov 1983