Cleared Traditional

JAUNDICE METER, MODEL JM 103 (K042522) - FDA 510(k) Clearance

Class I Chemistry device.

K042522 · Draeger Medical Infant Care, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
293d
Days
Class 1
Risk

K042522 is an FDA 510(k) clearance for the JAUNDICE METER, MODEL JM 103. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Draeger Medical Infant Care, Inc. (Hatboro, US). The FDA issued a Cleared decision on July 6, 2005 after a review of 293 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 Draeger Medical Infant Care, Inc. devices

Submission Details

510(k) Number K042522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2004
Decision Date July 06, 2005
Days to Decision 293 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
205d slower than avg
Panel avg: 88d · This submission: 293d
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.