Cleared Traditional

K110277 - RAPIDPOINT 405 NEONATAL BILIRUBIN (FDA 510(k) Clearance)

Class I Chemistry device.

K110277 · Siemens Healthcare Diagnostics · Chemistry device
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Aug 2011
Decision
196d
Days
Class 1
Risk

K110277 is an FDA 510(k) clearance for the RAPIDPOINT 405 NEONATAL BILIRUBIN. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Siemens Healthcare Diagnostics (Norowood, US). The FDA issued a Cleared decision on August 15, 2011 after a review of 196 days - an extended review cycle.

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.

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Submission Details

510(k) Number K110277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2011
Decision Date August 15, 2011
Days to Decision 196 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
108d slower than avg
Panel avg: 88d · This submission: 196d
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.