Cleared Traditional

K160712 - VITROS Chemistry Products hsCRP Reagent

K160712 is an FDA 510(k) clearance for VITROS Chemistry Products hsCRP Reagent, manufactured by Ortho-Clinical Diagnostics. The device is a Class 2 Chemistry device with product code DCK cleared through the Traditional 510(k) pathway after a 486-day FDA review.

K160712 · Ortho-Clinical Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
486d
Days
Class 2
Risk

K160712 is an FDA 510(k) clearance for the VITROS Chemistry Products hsCRP Reagent. Classified as C-reactive Protein, Antigen, Antiserum, And Control (product code DCK), Class II - Special Controls.

Submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on July 14, 2017 after a review of 486 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Ortho-Clinical Diagnostics devices

FDA 510(k) Submission Details - K160712

510(k) Number K160712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 2016
Decision Date July 14, 2017
Days to Decision 486 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
398d slower than avg
Panel avg: 88d · This submission: 486d
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 K160712.
Yumizen C1200 CRP
K192028 · HORIBA ABX SAS · Jun 2020
CRP Vario
K192118 · SENTINEL CH. SpA · Nov 2019
Yumizen C1200 CRP
K191993 · HORIBA ABX SAS · Oct 2019
QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument
K142993 · Orion Diagnostica, OY · Mar 2016
VITROS Chemistry Products CRP Slides
K152433 · Ortho-Clinical Diagnostics · Sep 2015
FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive Protein Calibrator Kit, FastPack High Sensitivity C-Reactive Protein Controls, FastPack High Sensitivity C-Reactive Protein Method Verification Kit
K141689 · Qualigen, Inc. · Jan 2015