Not Cleared Post-NSE

DEN040002 - NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS-8970 (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Post-NSE 510(k) pathway - typically does not require clinical trials.

DEN040002 · Perkinelmer Life Sciences, Inc. · Chemistry device
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Aug 2004
Decision
53d
Days
Class 2
Risk

DEN040002 is an FDA 510(k) submission (not cleared) for the NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT, MODEL MS.... Classified as System, Test, Amino Acids, Free Carnitines And Acylcarnitines Tandem Mass Spectrometry (product code NQL), Class II - Special Controls.

Submitted by Perkinelmer Life Sciences, Inc. (Norton, US). The FDA issued a Not Cleared (DENG) decision on August 24, 2004 after a review of 53 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Chemistry review framework.

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Submission Details

510(k) Number DEN040002 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received July 02, 2004
Decision Date August 24, 2004
Days to Decision 53 days
Submission Type Post-NSE
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 88d · This submission: 53d
Pathway characteristics

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.