Cleared Traditional

K130650 - STATUS DS OXY

K130650 is an FDA 510(k) clearance for STATUS DS OXY, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K130650 · Princeton BioMeditech Corp. · Toxicology device
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Feb 2014
Decision
352d
Days
Class 2
Risk

K130650 is an FDA 510(k) clearance for the STATUS DS OXY. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on February 26, 2014 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3650 - 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. Elevated predicate reliance profile. 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 Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K130650

510(k) Number K130650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2013
Decision Date February 26, 2014
Days to Decision 352 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
265d slower than avg
Panel avg: 87d · This submission: 352d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DJG Device Classification - Class 2, Special Controls

Product Code DJG Enzyme Immunoassay, Opiates
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3650
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 - DJG Enzyme Immunoassay, Opiates

All 188
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K130650.
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