Cleared Traditional

K213875 - DRI TM Tricyclics Serum Tox Assay

K213875 is an FDA 510(k) clearance for DRI TM Tricyclics Serum Tox Assay, manufactured by Microgenics Corporation. The device is a Class 2 Toxicology device with product code LFH cleared through the Traditional 510(k) pathway after a 373-day FDA review.

K213875 · Microgenics Corporation · Toxicology device
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Dec 2022
Decision
373d
Days
Class 2
Risk

K213875 is an FDA 510(k) clearance for the DRI TM Tricyclics Serum Tox Assay. Classified as U.v. Spectrometry, Tricyclic Antidepressant Drugs (product code LFH), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on December 21, 2022 after a review of 373 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3910 - 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microgenics Corporation devices

FDA 510(k) Submission Details - K213875

510(k) Number K213875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2021
Decision Date December 21, 2022
Days to Decision 373 days
Submission Type Traditional
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
286d slower than avg
Panel avg: 87d · This submission: 373d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LFH Device Classification - Class 2, Special Controls

Product Code LFH U.v. Spectrometry, Tricyclic Antidepressant Drugs
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3910
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 - LFH U.v. Spectrometry, Tricyclic Antidepressant Drugs

Devices cleared under the same product code (LFH) and FDA review panel - the closest regulatory comparables to K213875.
Alinity c Tricyclic Antidepressants Reagent Kit
K231020 · Microgenics Corporation · Nov 2023
MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY
K983268 · Diagnostic Reagents, Inc. · Nov 1998
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
K981801 · Princeton BioMeditech Corp. · Aug 1998
TRICYCLICS SERUM TOX ASSAY
K961393 · Diagnostic Reagents, Inc. · Jun 1996
AXSYM TRICYCLIC ANTIDEPRESSANTS
K953761 · Abbott Laboratories · Nov 1995