Cleared Traditional

ABL90 FLEX, ABL90 FLEX PLUS (K170882) - FDA 510(k) Clearance

Class I Chemistry device.

K170882 · Radiometer Medical Aps · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
35d
Days
Class 1
Risk

K170882 is an FDA 510(k) clearance for the ABL90 FLEX, ABL90 FLEX PLUS. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Radiometer Medical Aps (Broenshoej, DK). The FDA issued a Cleared decision on April 28, 2017 after a review of 35 days - a notably fast clearance 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: 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 Radiometer Medical Aps devices

Submission Details

510(k) Number K170882 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2017
Decision Date April 28, 2017
Days to Decision 35 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
53d faster than avg
Panel avg: 88d · This submission: 35d
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 K170882.
RAPIDPOINT 405 NEONATAL BILIRUBIN
K110277 · Siemens Healthcare Diagnostics · Aug 2011
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
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