Cleared Traditional

K091052 - PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM

K091052 is an FDA 510(k) clearance for PICCOLO C-REACTIVE PROTEIN (CRP) TEST S..., manufactured by Abaxis, Inc.. The device is a Class 2 Immunology device with product code DCN cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K091052 · Abaxis, Inc. · Immunology device
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Jan 2010
Decision
277d
Days
Class 2
Risk

K091052 is an FDA 510(k) clearance for the PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM. Classified as System, Test, C-reactive Protein (product code DCN), Class II - Special Controls.

Submitted by Abaxis, Inc. (Union City, US). The FDA issued a Cleared decision on January 15, 2010 after a review of 277 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Abaxis, Inc. devices

FDA 510(k) Submission Details - K091052

510(k) Number K091052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2009
Decision Date January 15, 2010
Days to Decision 277 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
172d slower than avg
Panel avg: 105d · This submission: 277d
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 57
Devices cleared under the same product code (DCN) and FDA review panel - the closest regulatory comparables to K091052.
MSD CRP Assay Kit and MESO SECTOR S 700 Instrument
K171498 · Meso Scale Diagnostics, LLC · Jan 2018
C-Reactive Protein Kit for use on SPAPLUS
K161982 · The Binding Site Group · Apr 2017
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
K113809 · Hitachi Chemical Diagnostics, Inc. · Aug 2012
C-REACTIVE PROTEIN (LATEX)
K083444 · Roche Diagnostics Corp. · Mar 2009
PATHFAST HSCRP
K083412 · Mitsubishi Kagaku Iatron · Mar 2009
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · Alfa Wassermann Diagnostic Technologies, Inc. · Jan 2009