Cleared Traditional

K896780 - MICRO DAU BENZODIAZEPINE ENZYME IMMUNOA...

K896780 is the FDA 510(k) clearance for MICRO DAU BENZODIAZEPINE ENZYME IMMUNOA... by Immunotech Corp.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K896780 · Immunotech Corp. · Toxicology device
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Mar 1990
Decision
109d
Days
Class 2
Risk

K896780 is an FDA 510(k) clearance for the MICRO DAU BENZODIAZEPINE ENZYME IMMUNOASSAY KIT. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Immunotech Corp. (Boston, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Toxicology review framework, consistent with the majority of Class II 510(k) submissions.

View all Immunotech Corp. devices

Submission Details

510(k) Number K896780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1989
Decision Date March 23, 1990
Days to Decision 109 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
22d slower than avg
Panel avg: 87d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 69
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K896780.
ABUSCREEN(R) ONLINE(TM) FOR BENZODIAZEPINES
K914509 · Roche Diagnostic Systems, Inc. · Nov 1991
ABUSCREEN ONTRAK FOR BENZODIAZEPINE
K910590 · Roche Diagnostic Systems, Inc. · Apr 1991
EMIT II BENZODIAZEPINE ASSAY
K910376 · Syva Co. · Feb 1991
BENZODIAZEPINES/TRICYCLIC ANTIDEPRESSANTS BY HPLC
K896744 · Bio-Rad · Feb 1990
ADX TM BENZODIAZEPINES
K890691 · Abbott Laboratories · Aug 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697 · Roche Diagnostic Systems, Inc. · Mar 1989