Cleared Traditional

K881941 - EMIT HVA OPIATE ASSAY

K881941 is the FDA 510(k) clearance for EMIT HVA OPIATE ASSAY by Syva Co.. It is a Class 2 Toxicology device (product code DJG) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K881941 · Syva Co. · Toxicology device
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Aug 1988
Decision
85d
Days
Class 2
Risk

K881941 is an FDA 510(k) clearance for the EMIT HVA OPIATE ASSAY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Syva Co. (Palo Alto, US). The FDA issued a Cleared decision on August 2, 1988 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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 K881941 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1988
Decision Date August 02, 1988
Days to Decision 85 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
2d faster than avg
Panel avg: 87d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 136
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K881941.
COAT-A-COUNT(TM) FENTANYL (TKFN1)
K891605 · Diagnostic Products Corp. · Sep 1989
ABUSCREEN FP FOR MORPHINE
K890888 · Roche Diagnostic Systems, Inc. · Mar 1989
ABUSCREEN(R) ONTRAK(TM) FOR MORPHINE
K882496 · Roche Diagnostic Systems, Inc. · Sep 1988
COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5
K874808 · Diagnostic Products Corp. · Feb 1988
REVISED LABELING FOR ADX OPIATES
K880010 · Abbott Laboratories · Feb 1988
REVISED LABELING FOR OPIATES
K874485 · Abbott Laboratories · Nov 1987