Cleared Special

K243498 - Alinity c Benzodiazepines Reagent Kit

K243498 is an FDA 510(k) clearance for Alinity c Benzodiazepines Reagent Kit, manufactured by Microgenics Corporation. The device is a Class 2 Toxicology device with product code JXM cleared through the Special 510(k) pathway after a 29-day FDA review.

K243498 · Microgenics Corporation · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2024
Decision
29d
Days
Class 2
Risk

K243498 is an FDA 510(k) clearance for the Alinity c Benzodiazepines Reagent Kit. Classified as Enzyme Immunoassay, Benzodiazepine (product code JXM), Class II - Special Controls.

Submitted by Microgenics Corporation (Fremont, US). The FDA issued a Cleared decision on December 11, 2024 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K243498

510(k) Number K243498 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2024
Decision Date December 11, 2024
Days to Decision 29 days
Submission Type Special
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
58d faster than avg
Panel avg: 87d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 89
Devices cleared under the same product code (JXM) and FDA review panel - the closest regulatory comparables to K243498.
ONLINE DAT Benzodiazepines II
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K153597 · Healgen Scientific, LLC · May 2016
K243498 · Alinity c Benzodiazepines Reagent Kit
Download PDF FDA Summary Microgenics Corporati…