Cleared Abbreviated

K123891 - SPARTAN RX CYP2C19 TEST SYSTEM (FDA 510(k) Clearance)

Class II Toxicology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K123891 · Spartan Bioscience, Inc. · Toxicology device
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Optimized for regulatory review, auditing and printing
Aug 2013
Decision
237d
Days
Class 2
Risk

K123891 is an FDA 510(k) clearance for the SPARTAN RX CYP2C19 TEST SYSTEM. Classified as Drug Metabolizing Enzyme Genotyping Systems (product code NTI), Class II - Special Controls.

Submitted by Spartan Bioscience, Inc. (Redwood Shores, US). The FDA issued a Cleared decision on August 12, 2013 after a review of 237 days - an extended review cycle.

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 Spartan Bioscience, Inc. devices

Submission Details

510(k) Number K123891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 2012
Decision Date August 12, 2013
Days to Decision 237 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
150d slower than avg
Panel avg: 87d · This submission: 237d
Pathway characteristics
Standards-based clearance path.

Device Classification

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.