Cleared Traditional

K971858 - SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)

K971858 is an FDA 510(k) clearance for SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/..., manufactured by Sigma Diagnostics, Inc.. The device is a Class 2 Hematology device with product code KQJ cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K971858 · Sigma Diagnostics, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
142d
Days
Class 2
Risk

K971858 is an FDA 510(k) clearance for the SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A). Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on October 9, 1997 after a review of 142 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 - K971858

510(k) Number K971858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1997
Decision Date October 09, 1997
Days to Decision 142 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 113d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KQJ Device Classification - Class 2, Special Controls

Product Code KQJ System, Fibrinogen Determination
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 - KQJ System, Fibrinogen Determination

All 27
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K971858.
HemosIL Fibrinogen-C
K251968 · Instrumentation Laboratory (IL) Co. · Jul 2025
HEMOSIL FIBRINOGEN-C
K073367 · Instrumentation Laboratory CO · Dec 2007
DADE THROMBIN REAGENT
K050928 · Dade Behring, Inc. · Jun 2005
FIF TM
K970189 · Panbio, Inc. · May 1997
N-ASSAY TIA FIBRINOGEN TEST KIT
K965113 · Crestat Diagnostics, Inc. · Apr 1997
MULTIFIBREN U
K934326 · Behring Diagnostics, Inc. · Apr 1994