Cleared Traditional

K983268 - MODIFICATION OF TRICYCLIC SERUM TOX EIA...

K983268 is the FDA 510(k) clearance for MODIFICATION OF TRICYCLIC SERUM TOX EIA... by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code LFH) cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K983268 · Diagnostic Reagents, Inc. · Toxicology device
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Nov 1998
Decision
62d
Days
Class 2
Risk

K983268 is an FDA 510(k) clearance for the MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAY. Classified as U.v. Spectrometry, Tricyclic Antidepressant Drugs (product code LFH), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 62 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K983268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1998
Decision Date November 18, 1998
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 87d · This submission: 62d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K983268.
Alinity c Tricyclic Antidepressants Reagent Kit
K231020 · Microgenics Corporation · Nov 2023
DRI TM Tricyclics Serum Tox Assay
K213875 · Microgenics Corporation · Dec 2022
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