Cleared Traditional

K051161 - QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)

K051161 is an FDA 510(k) clearance for QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETA..., manufactured by Quest Diagnostics, Inc.. The device is a Class 2 Toxicology device with product code DKZ cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K051161 · Quest Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2005
Decision
201d
Days
Class 2
Risk

K051161 is an FDA 510(k) clearance for the QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES). Classified as Enzyme Immunoassay, Amphetamine (product code DKZ), Class II - Special Controls.

Submitted by Quest Diagnostics, Inc. (Las Vegas, US). The FDA issued a Cleared decision on November 22, 2005 after a review of 201 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3100 - 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.

FDA 510(k) Submission Details - K051161

510(k) Number K051161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2005
Decision Date November 22, 2005
Days to Decision 201 days
Submission Type Traditional
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
114d slower than avg
Panel avg: 87d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DKZ Device Classification - Class 2, Special Controls

Product Code DKZ Enzyme Immunoassay, Amphetamine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3100
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 - DKZ Enzyme Immunoassay, Amphetamine

All 224
Devices cleared under the same product code (DKZ) and FDA review panel - the closest regulatory comparables to K051161.
ACRO BIOTECH LLC RAPID AMPHETAMINE URINE TEST
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AMEDITECH DRUGSMARTCUP
K053175 · Ameditech, Inc. · Dec 2005
SURE-SCREEN AMPHETAMINE, BENZODIAZEPINE, COCAINE, METHAMPHETAMINE/MDMA, METHADONE, OPIATES, PHENCYCLIDINE & CANNABINOIDS
K050394 · Medtox Diagnostics, Inc. · Oct 2005
IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS
K051579 · Immunalysis Corporation · Oct 2005
FIRST CHECK MULTI DRUG CUP 7 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
K051966 · Worldwide Medical, LLC · Sep 2005
K051161 · QUEST DIAGNOSTICS HAIRCHECK-DT (AMPHETAMINES)
Download PDF FDA Summary Quest Diagnostics, In…