Cleared Traditional

K090123 - NEONATAL BIOTINIDASE KIT, MODEL 3018 (FDA 510(k) Clearance)

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K090123 · Perkinelmer, Inc. · Chemistry device
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Mar 2010
Decision
408d
Days
Class 2
Risk

K090123 is an FDA 510(k) clearance for the NEONATAL BIOTINIDASE KIT, MODEL 3018. Classified as System, Test, Biotinidase (product code NAK), Class II - Special Controls.

Submitted by Perkinelmer, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 5, 2010 after a review of 408 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1118 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Chemistry submissions.

View all Perkinelmer, Inc. devices

Submission Details

510(k) Number K090123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date March 05, 2010
Days to Decision 408 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
320d slower than avg
Panel avg: 88d · This submission: 408d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NAK System, Test, Biotinidase
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1118
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.