Cleared Traditional

K930529 - BENZODIAZEPINE ENZYME IMMUNOASSAY

K930529 is the FDA 510(k) clearance for BENZODIAZEPINE ENZYME IMMUNOASSAY by Diagnostic Reagents, Inc.. It is a Class 2 Toxicology device (product code JXM) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K930529 · Diagnostic Reagents, Inc. · Toxicology device
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Aug 1993
Decision
184d
Days
Class 2
Risk

K930529 is an FDA 510(k) clearance for the BENZODIAZEPINE ENZYME IMMUNOASSAY. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Mountain View, US). The FDA issued a Cleared decision on August 5, 1993 after a review of 184 days - an extended review cycle.

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 Diagnostic Reagents, Inc. devices

Submission Details

510(k) Number K930529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1993
Decision Date August 05, 1993
Days to Decision 184 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
97d slower than avg
Panel avg: 87d · This submission: 184d
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 K930529.
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
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K931536 · Syva Co. · May 1993
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K926067 · Syva Co. · Jan 1993
EMIT D.A.U BENZODIAZEPINE ASSAY
K915501 · Syva Co. · Feb 1992