Cleared Traditional

K173568 - NeoBase 2 Non-derivatized MSMS Kit (FDA 510(k) Clearance)

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

K173568 · Wallac Oy, Subsidiary of Perkinelmer, Inc. · Chemistry device
Sep 2018
Decision
288d
Days
Class 2
Risk

K173568 is an FDA 510(k) clearance for the NeoBase 2 Non-derivatized MSMS Kit. Classified as System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry (product code NQL), Class II - Special Controls.

Submitted by Wallac Oy, Subsidiary of Perkinelmer, Inc. (Waltham, US). The FDA issued a Cleared decision on September 4, 2018 after a review of 288 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1055 - 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.

Submission Details

510(k) Number K173568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2017
Decision Date September 04, 2018
Days to Decision 288 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 234d · This submission: 288d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NQL System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1055
Definition Amino Acids, Free Carnitines And Acylcarnitines Test System Is Intended For The Measurement And Evaluation Of Amino Acid, Free Carnitine And Acylcarnitine Concentrations From Newborn Whole Blood Filter Paper Samples. The Quantitative Analysis Of The Amino Acids, Free Carnitines And Acylcarnitines And Their Relationship With Each Other Is Intended To Provide Analyte Concentration Profiles That Should Aid In Identifying Elevated Levels Of These Metabolites For Screening Newborns For One Or More Of Several Metabolic Disorders.
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.