Cleared Traditional

K190968 - CEDIA Benzodiazepine Assay

K190968 is an FDA 510(k) clearance for CEDIA Benzodiazepine Assay, manufactured by Microgenics Corporation. The device is a Class 2 Toxicology device with product code JXM cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K190968 · Microgenics Corporation · Toxicology device
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Dec 2019
Decision
241d
Days
Class 2
Risk

K190968 is an FDA 510(k) clearance for the CEDIA Benzodiazepine Assay. 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 9, 2019 after a review of 241 days - an extended review 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: 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 Microgenics Corporation devices

FDA 510(k) Submission Details - K190968

510(k) Number K190968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2019
Decision Date December 09, 2019
Days to Decision 241 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
154d slower than avg
Panel avg: 87d · This submission: 241d
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 84
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