Cleared Traditional

K883730 - TDX BENZODIAZEPINES SERUM

K883730 is an FDA 510(k) clearance for TDX BENZODIAZEPINES SERUM, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K883730 · Abbott Laboratories · Toxicology device
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Nov 1988
Decision
90d
Days
Class 2
Risk

K883730 is an FDA 510(k) clearance for the TDX BENZODIAZEPINES SERUM. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 29, 1988 after a review of 90 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 Abbott Laboratories devices

FDA 510(k) Submission Details - K883730

510(k) Number K883730 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1988
Decision Date November 29, 1988
Days to Decision 90 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
3d slower than avg
Panel avg: 87d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

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 75
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K883730.
ADX TM BENZODIAZEPINES
K890691 · Abbott Laboratories · Aug 1989
ABUSCREEN FP BENZODIAZEPHINE REAGENT
K891697 · Roche Diagnostic Systems, Inc. · Mar 1989
DOUBLE ANTIBODY SERUM BENZODIAZEPINES
K890001 · Diagnostic Products Corp. · Jan 1989
DOUBLE ANTIBODY BENZODIAZPINES #KBZD1, KBZD5
K883459 · Diagnostic Products Corp. · Sep 1988
REVISIED LABELING FOR ADX BENZODIAZEPINES
K880014 · Abbott Laboratories · Feb 1988
REVISED LABELING FOR SYVA BENZODIAZEPINE ASSAYS
K874376 · Syva Co. · Nov 1987