Cleared Traditional

K983071 - BILICHEK NON-INVASIVE BILIRUBIN ANALYZER

K983071 is an FDA 510(k) clearance for BILICHEK NON-INVASIVE BILIRUBIN ANALYZER, manufactured by Respironics, Inc.. The device is a Class 1 Chemistry device with product code MQM cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K983071 · Respironics, Inc. · Chemistry device
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Mar 1999
Decision
183d
Days
Class 1
Risk

K983071 is an FDA 510(k) clearance for the BILICHEK NON-INVASIVE BILIRUBIN ANALYZER. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Respironics, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on March 4, 1999 after a review of 183 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 Respironics, Inc. devices

FDA 510(k) Submission Details - K983071

510(k) Number K983071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1998
Decision Date March 04, 1999
Days to Decision 183 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 88d · This submission: 183d
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 12
Devices cleared under the same product code (MQM) and FDA review panel - the closest regulatory comparables to K983071.
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
K994438 · Spectrx, Inc. · Feb 2000
NBIL
K983134 · Abbott Laboratories · Sep 1998
JM-102 JAUNDICE METER
K972309 · Air-Shields, Inc. · Sep 1998
IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER FOR NEONATE WHOLE BLOOD SAMPLES
K980646 · Instrumentation Laboratory CO · May 1998