Cleared Traditional

K133175 - DRAEGER JAUNDICE METER JM-105 (FDA 510(k) Clearance)

Class I Chemistry device.

K133175 · Draeger Medical Systems, Inc. · Chemistry device
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Nov 2014
Decision
392d
Days
Class 1
Risk

K133175 is an FDA 510(k) clearance for the DRAEGER JAUNDICE METER JM-105. Classified as Bilirubin (total And Unbound) In The Neonate Test System (product code MQM), Class I - General Controls.

Submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on November 13, 2014 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Systems, Inc. devices

Submission Details

510(k) Number K133175 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 2013
Decision Date November 13, 2014
Days to Decision 392 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
304d slower than avg
Panel avg: 88d · This submission: 392d
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.