Cleared Traditional

K183530 - TruDiagnosis System (FDA 510(k) Clearance)

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

K183530 · Akonni Biosystems, Inc. · Toxicology device
May 2019
Decision
156d
Days
Class 2
Risk

K183530 is an FDA 510(k) clearance for the TruDiagnosis System. Classified as Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System (product code ODW), Class II - Special Controls.

Submitted by Akonni Biosystems, Inc. (Frederick, US). The FDA issued a Cleared decision on May 24, 2019 after a review of 156 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 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 Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K183530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2018
Decision Date May 24, 2019
Days to Decision 156 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 147d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ODW Cytochrome P450 2c9 (cyp450 2c9) Drug Metabolizing Enzyme Genotyping System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3360
Definition An In Vitro Diagnostic Assay For Use In Genotyping Cytochrome P450 2c9 (cyp450 2c9) Alleles. Information About The Cyp2c9 Genotype May Be Used As An Aid To Clinicians In Determining Therapeutic Strategy For Medications That Are Metabolized By The Cyp2c9 Gene Product.
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.