Cleared Traditional

K051958 - MP RAPIDOXY TEST STRIP, MODEL 07RD-7073

K051958 is an FDA 510(k) clearance for MP RAPIDOXY TEST STRIP, manufactured by Mp Biomedicals, LLC. The device is a Class 2 Toxicology device with product code DJG cleared through the Traditional 510(k) pathway after a 367-day FDA review.

K051958 · Mp Biomedicals, LLC · Toxicology device
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Jul 2006
Decision
367d
Days
Class 2
Risk

K051958 is an FDA 510(k) clearance for the MP RAPIDOXY TEST STRIP, MODEL 07RD-7073. Classified as Enzyme Immunoassay, Opiates (product code DJG), Class II - Special Controls.

Submitted by Mp Biomedicals, LLC (Northridge, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 367 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 Mp Biomedicals, LLC devices

FDA 510(k) Submission Details - K051958

510(k) Number K051958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2005
Decision Date July 21, 2006
Days to Decision 367 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
280d slower than avg
Panel avg: 87d · This submission: 367d
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 189
Devices cleared under the same product code (DJG) and FDA review panel - the closest regulatory comparables to K051958.
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K060351 · Medtox Diagnostics, Inc. · May 2006
ACON BUP ONE STEP BUPRENORPHINE TEST STRIP AND ACRON BUP ONE STEP BUPRENORPHINE TEST DEVICE
K060466 · ACON Laboratories, Inc. · Apr 2006
IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS
K051626 · Immunalysis Corporation · Oct 2005