Cleared Traditional

K951288 - AXSYM CANNABINOIDS

K951288 is an FDA 510(k) clearance for AXSYM CANNABINOIDS, manufactured by Abbott Laboratories. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K951288 · Abbott Laboratories · Toxicology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
56d
Days
Class 2
Risk

K951288 is an FDA 510(k) clearance for the AXSYM CANNABINOIDS. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 16, 1995 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3170 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Abbott Laboratories devices

FDA 510(k) Submission Details - K951288

510(k) Number K951288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1995
Decision Date May 16, 1995
Days to Decision 56 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
31d faster than avg
Panel avg: 87d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXM Device Classification - Class 2, Special Controls

Product Code JXM Enzyme Immunoassay, Benzodiazepine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3170
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 - JXM Enzyme Immunoassay, Benzodiazepine

All 75
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K951288.
CEDIA DAU BENZODIAZEPINE ASSAY(MODIFICATION)
K954626 · Microgenics Corp. · Nov 1995
CEDIA DAU BENZODIAZEPINE ASSAY
K951710 · Microgenics Corp. · Jun 1995
AXSYM BENZODIAZEPINES
K951286 · Abbott Laboratories · May 1995
URINE BENZODIAZEPINES SCREEN FLEX TEAGENT CARTRIDGE
K950427 · E.I. Dupont DE Nemours & Co., Inc. · Mar 1995
CX(TM) BENZODIAZEPINE(BENZ) REAGENT FOR SYCHRON CX SYS
K944076 · Beckman Instruments, Inc. · Nov 1994
CEDIA DAU BENZODIAZEPINE ASSAY
K942795 · Microgenics Corp. · Aug 1994