Cleared Traditional

K050836 - CRP DIAGNOSTIC ASSAY

K050836 is an FDA 510(k) clearance for CRP DIAGNOSTIC ASSAY, manufactured by Sentinel Ch. Srl. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K050836 · Sentinel Ch. Srl · Chemistry device
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Aug 2005
Decision
129d
Days
Class 2
Risk

K050836 is an FDA 510(k) clearance for the CRP DIAGNOSTIC ASSAY. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Sentinel Ch. Srl (Rome, IT). The FDA issued a Cleared decision on August 8, 2005 after a review of 129 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.5270 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Sentinel Ch. Srl devices

FDA 510(k) Submission Details - K050836

510(k) Number K050836 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2005
Decision Date August 08, 2005
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d slower than avg
Panel avg: 88d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DCK Device Classification - Class 2, Special Controls

Product Code DCK C-reactive Protein, Antigen, Antiserum, And Control
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 Chemistry devices follow this clearance model.

Regulatory Peers - DCK C-reactive Protein, Antigen, Antiserum, And Control

All 105
Devices cleared under the same product code (DCK) and FDA review panel - the closest regulatory comparables to K050836.
ABX PENTRA 400 : CRP
K061138 · Horiba Abx · Sep 2006
CRP-ADVANCE ASSAY, MODELS 250-20, 250-25
K060139 · Diagnostic Chemicals , Ltd. · Apr 2006
NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT
K052591 · Clinical Data, Inc. · Feb 2006
WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY
K041155 · Stanbio Laboratory · Oct 2004
QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085
K042442 · Orion Diagnostica, OY · Sep 2004
N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET
K040241 · Genzyme Corp. · Jun 2004