Cleared Abbreviated

K060527 - INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST

Also marketed or referenced as:
INSTANT-CONFIRMATORY BUP/NBUP URINE TEST

K060527 is an FDA 510(k) clearance for INSTANT-VIEW BUP/NBUP URINE TEST. INSTA..., manufactured by Alfa Scientific Designs, Inc.. The device is a Class 2 Toxicology device with product code DJG cleared through the Abbreviated 510(k) pathway after a 147-day FDA review.

K060527 · Alfa Scientific Designs, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
147d
Days
Class 2
Risk

K060527 is an FDA 510(k) clearance for the INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Alfa Scientific Designs, Inc. (Powat, US). The FDA issued a Cleared decision on July 25, 2006 after a review of 147 days - within the typical 510(k) review window.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - the FDA toxicology device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K060527

510(k) Number K060527 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2006
Decision Date July 25, 2006
Days to Decision 147 days
Submission Type Abbreviated
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 87d · This submission: 147d
Pathway characteristics
Standards-based clearance path.

DJG Device Classification - Class 2, Special Controls

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 214
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K060527.
AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150
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K062460 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
RAPIDONE-BUPRENORPHINE TEST
K060760 · American Bio Medica Corp. · Aug 2006
MP RAPIDOXY TEST STRIP, MODEL 07RD-7073
K051958 · Mp Biomedicals, LLC · Jul 2006
ACRO BIOTECH LLC RAPID OPIATES URINE TEST
K053037 · Acro Biotech, LLC · Jun 2006
MEDTOX OXYCODONE
K060351 · Medtox Diagnostics, Inc. · May 2006
K060527 · INSTANT-VIEW BUP/NBUP URINE TEST. INSTANT-VERDICT BUP/NBUP URINE TEST
Download PDF FDA Summary Alfa Scientific Desig…