Cleared Traditional

K173833 - CRP Vario (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173833 · SENTINEL CH. SpA · Chemistry device
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Sep 2018
Decision
283d
Days
Class 2
Risk

K173833 is an FDA 510(k) clearance for the CRP Vario. Classified as Cardiac C-reactive Protein, Antigen, Antiserum, And Control (product code NQD), Class II - Special Controls.

Submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on September 27, 2018 after a review of 283 days - an extended review cycle.

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. SpA devices

Submission Details

510(k) Number K173833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2017
Decision Date September 27, 2018
Days to Decision 283 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
195d slower than avg
Panel avg: 88d · This submission: 283d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5270
Definition In Vitro Diagnostic Test To Measure C-reactive Protein For The Purpose Of Making Cardiac Risk Assessments.
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 - NQD Cardiac C-reactive Protein, Antigen, Antiserum, And Control

All 18
Devices cleared under the same product code (NQD) and FDA review panel - the closest regulatory comparables to K173833.
Tina-quant Cardiac high sensitivity CRP III
K260026 · Roche Diagnostics · Apr 2026
Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)
K233242 · Siemens Healthcare Diagnostics, Inc. · Jan 2024
CardioPhase® hsCRP
K212559 · Siemens Healthcare Diagnostics Products GmbH · Dec 2022