Cleared Traditional

K900939 - SPQ TEST SYSTEM II FOR FIB (SERUM PROTEIN QUANTI.)

K900939 is an FDA 510(k) clearance for SPQ TEST SYSTEM II FOR FIB (SERUM PROTE..., manufactured by Incstar Corp.. The device is a Class 2 Hematology device with 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

FDA 510(k) Submission Details - K900939

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.

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 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