Cleared Traditional

K060354 - ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000

K060354 is an FDA 510(k) clearance for ACRO BIOTECH LLC RAPID BENZODIAZEPINE U..., manufactured by Acro Biotech, LLC. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K060354 · Acro Biotech, LLC · Toxicology device
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Jul 2006
Decision
165d
Days
Class 2
Risk

K060354 is an FDA 510(k) clearance for the ACRO BIOTECH LLC RAPID BENZODIAZEPINE URINE TEST, CATALOG BZD001000. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Acro Biotech, LLC (Rancho Cucamonga, US). The FDA issued a Cleared decision on July 28, 2006 after a review of 165 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 Acro Biotech, LLC devices

FDA 510(k) Submission Details - K060354

510(k) Number K060354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2006
Decision Date July 28, 2006
Days to Decision 165 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
78d slower than avg
Panel avg: 87d · This submission: 165d
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 85
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K060354.
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K062285 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
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K051307 · Beckman Coulter, Inc. · Jun 2005
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K050179 · Randox Laboratories, Ltd. · May 2005
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K043556 · Beckman Coulter, Inc. · Mar 2005