Cleared Traditional

TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE) (K042485) - FDA 510(k) Clearance

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

K042485 · Roche Diagnostics Corp. · Chemistry device
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Oct 2004
Decision
46d
Days
Class 2
Risk

K042485 is an FDA 510(k) clearance for the TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LATEX) HIGH SENSIT.... Classified as Cardiac C-reactive Protein, Antigen, Antiserum, And Control (product code NQD), Class II - Special Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on October 29, 2004 after a review of 46 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Roche Diagnostics Corp. devices

Submission Details

510(k) Number K042485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2004
Decision Date October 29, 2004
Days to Decision 46 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
42d faster than avg
Panel avg: 88d · This submission: 46d
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 K042485.
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
CRP Vario
K173833 · SENTINEL CH. SpA · Sep 2018