Cleared Traditional

K040174 - BILIRUBIN ASSAY ON THE OMNI S ANALYZER

K040174 is the FDA 510(k) clearance for BILIRUBIN ASSAY ON THE OMNI S ANALYZER by Roche Diagnostics Corp.. It is a Class 1 Chemistry device (product code MQM) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K040174 · Roche Diagnostics Corp. · Chemistry device
Download Printable Device Report (PDF)
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May 2004
Decision
109d
Days
Class 1
Risk

K040174 is an FDA 510(k) clearance for the BILIRUBIN ASSAY ON THE OMNI S ANALYZER. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on May 14, 2004 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1113 - 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 Roche Diagnostics Corp. devices

Submission Details

510(k) Number K040174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date May 14, 2004
Days to Decision 109 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
21d slower than avg
Panel avg: 88d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MQM Bilirubin (total And Unbound) In The Neonate Test System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1113
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MQM Bilirubin (total And Unbound) In The Neonate Test System

Devices cleared under the same product code (MQM) and FDA review panel - the closest regulatory comparables to K040174.
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277 · Siemens Healthcare Diagnostics · Aug 2011
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · Respironics, Inc. · Mar 2001
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · Respironics, Inc. · Mar 1999
NBIL
K983134 · Abbott Laboratories · Sep 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
K980646 · Instrumentation Laboratory CO · May 1998