Cleared Traditional

K042726 - QUEST DIAGNOSTICS HAIRCHECK-DT (PCP

K042726 · Quest Diagnostics, Inc. · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
300d
Days
-
Risk

K042726 is an FDA 510(k) clearance for the QUEST DIAGNOSTICS HAIRCHECK-DT (PCP. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Quest Diagnostics, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 28, 2005 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel. 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 Quest Diagnostics, Inc. devices

Submission Details

510(k) Number K042726 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 2004
Decision Date July 28, 2005
Days to Decision 300 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 87d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

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