Cleared Abbreviated

K123891 - SPARTAN RX CYP2C19 TEST SYSTEM

K123891 is an FDA 510(k) clearance for SPARTAN RX CYP2C19 TEST SYSTEM, manufactured by Spartan Bioscience, Inc.. The device is a Class 2 Toxicology device with product code NTI cleared through the Abbreviated 510(k) pathway after a 237-day FDA review.

K123891 · Spartan Bioscience, Inc. · Toxicology device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K123891

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
150d slower than avg
Panel avg: 87d · This submission: 237d
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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Toxicology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01676298 Completed Observational Industry-sponsored

Spartan FRX Project Reproducibility Study

Study of the Analytical Reproducibility of the Spartan FRX CYP2C19 *2,*3 and *17 Genotyping System.

8
Patients (actual)
3
Sites
Condition studied Analytical Reproducibility of a Medical Device
Eligibility All sexes · 16 Years+ · Healthy volunteers accepted
Principal investigator Chris JE Harder, PhD
Sponsor Spartan Bioscience Inc. (industry)
Started 2012-08-01 → Primary completion 2012-09-01 → Completed 2012-11-01
Primary outcome
Percentage of Correct Calls to Assess Reproducibility of the Spartan FRX CYP2C19 System.
View full study on ClinicalTrials.gov

Regulatory Peers - NTI Drug Metabolizing Enzyme Genotyping Systems

All 9
Devices cleared under the same product code (NTI) and FDA review panel - the closest regulatory comparables to K123891.
Genomadix Cube CYP2C19 System
K220026 · Genomadix, Inc. · Mar 2023
xTAG CYP2D6 Kit v3
K170492 · Luminex Molecular Diagnostics, Inc. · Aug 2017
XTAG CYP2C19 KIT V3
K131565 · Luminex Molecular Diagnostics, Inc. · Sep 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