Cleared Traditional

K983188 - DBEST TETRAHYDROCANNABINOL TEST KIT

K983188 is an FDA 510(k) clearance for DBEST TETRAHYDROCANNABINOL TEST KIT, manufactured by Ameritek, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K983188 · Ameritek, Inc. · Toxicology device
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Nov 1998
Decision
68d
Days
Class 2
Risk

K983188 is an FDA 510(k) clearance for the DBEST TETRAHYDROCANNABINOL TEST KIT. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Ameritek, Inc. (Seattle, US). The FDA issued a Cleared decision on November 18, 1998 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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 Ameritek, Inc. devices

FDA 510(k) Submission Details - K983188

510(k) Number K983188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1998
Decision Date November 18, 1998
Days to Decision 68 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
19d faster than avg
Panel avg: 87d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 124
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K983188.
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K981584 · Roche Diagnostic Systems, Inc. · May 1998