Cleared Traditional

K935075 - SPQ CRP CONTROL LEVEL II

K935075 is an FDA 510(k) clearance for SPQ CRP CONTROL LEVEL II, manufactured by Incstar Corp.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K935075 · Incstar Corp. · Immunology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 1994
Decision
78d
Days
Class 2
Risk

K935075 is an FDA 510(k) clearance for the SPQ CRP CONTROL LEVEL II. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Incstar Corp. (Stillwater, US). The FDA issued a Cleared decision on January 11, 1994 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5270 - the FDA immunology 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.

FDA 510(k) Submission Details - K935075

510(k) Number K935075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1993
Decision Date January 11, 1994
Days to Decision 78 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 105d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCN Device Classification - Class 2, Special Controls

Product Code DCN System, Test, C-reactive Protein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
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 Immunology devices follow this clearance model.

Regulatory Peers - DCN System, Test, C-reactive Protein

All 69
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K935075.
RAPET CRP
K974429 · Stanbio Laboratory · Feb 1998
OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT
K954537 · Olympus America, Inc. · Feb 1996
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
K955042 · Shared Systems, Inc. · Dec 1995
EYE SPOT CRP TEST
K932180 · J.S. Medical Assoc. · Aug 1993
SYNCHRON C-REACTIVE PROTEIN REAGENT
K910535 · Beckman Instruments, Inc. · Apr 1991
RHEUMAJET CRP
K910686 · Biokit USA, Inc. · Mar 1991
K935075 · SPQ CRP CONTROL LEVEL II
Download PDF FDA Summary Incstar Corp.