Cleared Traditional

K110277 - RAPIDPOINT 405 NEONATAL BILIRUBIN

K110277 is an FDA 510(k) clearance for RAPIDPOINT 405 NEONATAL BILIRUBIN, manufactured by Siemens Healthcare Diagnostics. The device is a Class 1 Chemistry device with product code MQM cleared through the Traditional 510(k) pathway after a 196-day FDA review.

K110277 · Siemens Healthcare Diagnostics · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Siemens Healthcare Diagnostics devices

FDA 510(k) Submission Details - K110277

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
108d slower than avg
Panel avg: 88d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

MQM Device Classification - Class 1, General Controls

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

All 9
Devices cleared under the same product code (MQM) and FDA review panel - the closest regulatory comparables to K110277.
ABL90 FLEX, ABL90 FLEX PLUS
K170882 · Radiometer Medical Aps · Apr 2017
ABL90 FLEX
K132691 · Radiometer Medical Aps · Nov 2014
DRAEGER JAUNDICE METER JM-105
K133175 · Draeger Medical Systems, Inc. · Nov 2014
BILIRUBIN ASSAY ON THE OMNI S ANALYZER
K040174 · Roche Diagnostics Corp. · May 2004
RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20
K010052 · Respironics, Inc. · Mar 2001
BILICHEK NON-INVASIVE BILIRUBIN ANALYZER
K983071 · Respironics, Inc. · Mar 1999