Cleared Traditional

K953534 - AXSYM PHENCYCLIDINE II

K953534 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
91d
Days
-
Risk

K953534 is an FDA 510(k) clearance for the AXSYM PHENCYCLIDINE II. Classified as Enzyme Immunoassay, Phencyclidine (product code LCM).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on October 26, 1995 after a review of 91 days - within the typical 510(k) review window.

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.

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FDA 510(k) Submission Details - K953534

510(k) Number K953534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date October 26, 1995
Days to Decision 91 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
4d slower than avg
Panel avg: 87d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

LCM Device Classification - Class 0,

Product Code LCM Enzyme Immunoassay, Phencyclidine
Device Class -

Regulatory Peers - LCM Enzyme Immunoassay, Phencyclidine

All 62
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CEDIA(R) DAU PCP ASSAY
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