Cleared Traditional

K843421 - EMIT 700 CANNABINOID ASSAY

K843421 is the FDA 510(k) clearance for EMIT 700 CANNABINOID ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code LDJ) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K843421 · Syva Co. · Toxicology device
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Sep 1984
Decision
25d
Days
Class 2
Risk

K843421 is an FDA 510(k) clearance for the EMIT 700 CANNABINOID ASSAY. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Syva Co. (Mchenry, US). The FDA issued a Cleared decision on September 25, 1984 after a review of 25 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 Syva Co. devices

Submission Details

510(k) Number K843421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date September 25, 1984
Days to Decision 25 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
62d faster than avg
Panel avg: 87d · This submission: 25d
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 85
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K843421.
TDXR CANNABINOIDS
K864751 · Abbott Laboratories · Mar 1987
EMIT D.A.U. CANNABINOID 20NG ASSAY
K860500 · Syva Co. · Apr 1986
EMIT 700 CANNABINOID 20 ASSAY
K851373 · Syva Co. · May 1985
EMIT D.A.U. URINE CANNABINOID ASSAY
K834458 · Syva Co. · Jun 1984
EMIT ST URINE CANNABINOID ASSAY
K841238 · Syva Co. · Jun 1984
MODIF. OF EMIT URINE CANNABINOID
K833580 · Syva Co. · Jan 1984