Cleared Traditional

K900939 - SPQ TEST SYSTEM II FOR FIB (SERUM PROTE...

K900939 is the FDA 510(k) clearance for SPQ TEST SYSTEM II FOR FIB (SERUM PROTE... by Incstar Corp.. It is a Class 2 Hematology device (product code KQJ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K900939 · Incstar Corp. · Hematology device
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May 1990
Decision
77d
Days
Class 2
Risk

K900939 is an FDA 510(k) clearance for the SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.). Classified as System, Fibrinogen Determination (product code KQJ), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on May 16, 1990 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Incstar Corp. devices

Submission Details

510(k) Number K900939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 1990
Decision Date May 16, 1990
Days to Decision 77 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 113d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 21
Devices cleared under the same product code (KQJ) and FDA review panel - the closest regulatory comparables to K900939.
MULTIFIBREN
K925988 · Behring Diagnostics, Inc. · Mar 1993
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
K923593 · International Technidyne Corp. · Sep 1992
QBC FIBRINOGEN
K920258 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1992
COAG-A-MATE - RA4
K900895 · Organon Teknika Corp. · Apr 1990
FIBRINOGEN ASSAY KIT
K896052 · Medical Diagnostic Technologies, Inc. · Nov 1989
TURBOX FIBRINOGEN
K884179 · Unipath , Ltd. · Dec 1988