Cleared Traditional

K140665 - GenPrime Snap-Top Split Key Cup

K140665 is an FDA 510(k) clearance for GenPrime Snap-Top Split Key Cup, manufactured by Genprime, Inc.. The device is a Class 2 Toxicology device with product code DIS cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K140665 · Genprime, Inc. · Toxicology device
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Dec 2014
Decision
265d
Days
Class 2
Risk

K140665 is an FDA 510(k) clearance for the GenPrime Snap-Top Split Key Cup. Classified as Enzyme Immunoassay, Barbiturate (product code DIS), Class II - Special Controls.

Submitted by Genprime, Inc. (Spokane, US). The FDA issued a Cleared decision on December 8, 2014 after a review of 265 days - an extended review cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3150 - 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 Genprime, Inc. devices

FDA 510(k) Submission Details - K140665

510(k) Number K140665 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2014
Decision Date December 08, 2014
Days to Decision 265 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
178d slower than avg
Panel avg: 87d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DIS Device Classification - Class 2, Special Controls

Product Code DIS Enzyme Immunoassay, Barbiturate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3150
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 Consultant

Newworld Regulatory Solutions, Inc.
Maureen Garner

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DIS Enzyme Immunoassay, Barbiturate

All 89
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