Cleared Traditional

K041747 - IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)

K041747 is an FDA 510(k) clearance for IMPACT TEST SYSTEM SALIVA TEST MODULE-O..., manufactured by Lifepoint,Inc. The device is a Class 2 Chemistry device with product code DJG cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K041747 · Lifepoint,Inc · Chemistry device
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Nov 2004
Decision
148d
Days
Class 2
Risk

K041747 is an FDA 510(k) clearance for the IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE). Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Lifepoint,Inc (Ontario, US). The FDA issued a Cleared decision on November 24, 2004 after a review of 148 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3650 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Lifepoint,Inc devices

FDA 510(k) Submission Details - K041747

510(k) Number K041747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2004
Decision Date November 24, 2004
Days to Decision 148 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
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: 88d · This submission: 148d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Chemistry devices follow this clearance model.

Regulatory Peers - DJG Enzyme Immunoassay, Opiates

All 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K041747.
FOR SURE ONE STEP BUPRENORPHINE TEST STRIP
K042990 · Tianjin New Bay Bioresearch Co., Ltd. · May 2005
ACON OXY II ONE STEP OXYCODONE TEST STRIP
K043507 · ACON Laboratories, Inc. · Feb 2005
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
K043051 · Phamatech, Inc. · Feb 2005
IMPACT TEST SYSTEM
K041746 · Lifepoint,Inc · Nov 2004
RANDOX OPIATES ASSAY
K041144 · Randox Laboratories, Ltd. · Nov 2004
CEDIA BUPRENORPHINE ASSAY
K040316 · Microgenics Corp. · Jun 2004