Cleared Traditional

K871695 - DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND ...

K871695 is the FDA 510(k) clearance for DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND ... by Diagnostic Products Corp.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K871695 · Diagnostic Products Corp. · Toxicology device
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Jun 1987
Decision
36d
Days
Class 2
Risk

K871695 is an FDA 510(k) clearance for the DOUBLE ANTIBODY CANNABINOIDS KTHD1 AND KTHD5. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on June 5, 1987 after a review of 36 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 Diagnostic Products Corp. devices

Submission Details

510(k) Number K871695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1987
Decision Date June 05, 1987
Days to Decision 36 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 87d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 80
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K871695.
REVISED LABELING FOR SYVA CANNABINOID ASSAYS
K874079 · Syva Co. · Oct 1987
STICKER LABEL FOR DRUGS OF ABUSE ASSAYS
K874156 · Syva Co. · Oct 1987
LABELING CHANGE CANNABINOIDS DOUBLE ANTI. IN URINE
K873753 · Diagnostic Products Corp. · Oct 1987
ABUSCREEN (R) EIA CANNABINOIDS
K870377 · Roche Diagnostic Systems, Inc. · Mar 1987
TDXR CANNABINOIDS
K864751 · Abbott Laboratories · Mar 1987
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500 · Syva Co. · Apr 1986