Cleared Traditional

K131284 - GSP NEONATAL BIOTINIDASE KIT (FDA 510(k) Clearance)

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

K131284 · Wallac OY · Chemistry device
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Nov 2013
Decision
192d
Days
Class 2
Risk

K131284 is an FDA 510(k) clearance for the GSP NEONATAL BIOTINIDASE KIT. Classified as System, Test, Biotinidase (product code NAK), Class II - Special Controls.

Submitted by Wallac OY (Waltham, US). The FDA issued a Cleared decision on November 14, 2013 after a review of 192 days - an extended review cycle.

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: 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.

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Submission Details

510(k) Number K131284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2013
Decision Date November 14, 2013
Days to Decision 192 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
104d slower than avg
Panel avg: 88d · This submission: 192d
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.