Cleared Abbreviated

K101683 - INFINITI CYP2C19 ASSAY

K101683 is an FDA 510(k) clearance for INFINITI CYP2C19 ASSAY, manufactured by Autogenomics, Incorporated. The device is a Class 2 Toxicology device with product code NTI cleared through the Abbreviated 510(k) pathway after a 132-day FDA review.

K101683 · Autogenomics, Incorporated · Toxicology device
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Optimized for regulatory review, auditing and printing
Oct 2010
Decision
132d
Days
Class 2
Risk

K101683 is an FDA 510(k) clearance for the INFINITI CYP2C19 ASSAY. Classified as Drug Metabolizing Enzyme Genotyping Systems (product code NTI), Class II - Special Controls.

Submitted by Autogenomics, Incorporated (Vista, US). The FDA issued a Cleared decision on October 25, 2010 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3360 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Autogenomics, Incorporated devices

FDA 510(k) Submission Details - K101683

510(k) Number K101683 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2010
Decision Date October 25, 2010
Days to Decision 132 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 87d · This submission: 132d
Pathway characteristics
Standards-based clearance path.

NTI Device Classification - Class 2, Special Controls

Product Code NTI Drug Metabolizing Enzyme Genotyping Systems
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3360
Definition Intended To Identify The Presence Or Absence Of Human Genotypic Markers Encoding Drug Metaboizing Enzymes Using Dna Originating From Clinical Samples. This Type Of Assay Can Be Used As An Aid Determining Treatment Choice And Individualizing Treatment Dose For Therapeutics That Are Metabolized Primarily By The Specific Enzyme Tested By The System.
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 Toxicology devices follow this clearance model.

Regulatory Peers - NTI Drug Metabolizing Enzyme Genotyping Systems

All 10
Devices cleared under the same product code (NTI) and FDA review panel - the closest regulatory comparables to K101683.
SPARTAN RX CYP2C19 TEST SYSTEM
K123891 · Spartan Bioscience, Inc. · Aug 2013
XTAG CYP2D6 KIT V3 (INCLUDING TDAS CYP2D6 SOFTWARE)
K130189 · Luminex Molecular Diagnostics, Inc. · May 2013
VERIGENE CYP2C19 NUCLEIC ACID TES (2C19)
K120466 · Nanosphere, Inc. · Nov 2012
XTAG CYP2D6 KIT V3, MODEL I030C0300 (96 TESTS/KIT), TDAS CYP2D6 SOFTWARE (2030-0254)
K093420 · Luminex Molecular Diagnostics, Inc. · Aug 2010
INVADER UGT1A1 MOLECULAR ASSAY
K051824 · Third Wave Technologies, Inc. · Aug 2005
ROCHE AMPLICHIP CYP450 TEST
K043576 · Roche Molecular Systems, Inc. · Jan 2005