Cleared Special

K991751 - STATUS CUP ACCUSIGN CUP

K991751 is an FDA 510(k) clearance for STATUS CUP ACCUSIGN CUP, manufactured by Princeton BioMeditech Corp.. The device is a Class 2 Toxicology device with product code DKE cleared through the Special 510(k) pathway after a 25-day FDA review.

K991751 · Princeton BioMeditech Corp. · Toxicology device
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Jun 1999
Decision
25d
Days
Class 2
Risk

K991751 is an FDA 510(k) clearance for the STATUS CUP ACCUSIGN CUP. Classified as Reagents, Test, Tetrahydrocannabinol (product code DKE), Class II - Special Controls.

Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on June 18, 1999 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3870 - 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.

View all Princeton BioMeditech Corp. devices

FDA 510(k) Submission Details - K991751

510(k) Number K991751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 1999
Decision Date June 18, 1999
Days to Decision 25 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 87d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

DKE Device Classification - Class 2, Special Controls

Product Code DKE Reagents, Test, Tetrahydrocannabinol
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3870
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 - DKE Reagents, Test, Tetrahydrocannabinol

Devices cleared under the same product code (DKE) and FDA review panel - the closest regulatory comparables to K991751.
INSTANT-VIEW MARIJUANA URINE CASSETTE TEST
K994405 · Alfa Scientific Designs, Inc. · Jun 2000
STATUS STIK, ACCUSIGN STIK
K992068 · Princeton BioMeditech Corp. · Jul 1999
ACCUSIGN DOA8, DOA8 PANEL, THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA8, THC/OPI/COC/AMP/BZO/BAR/TCA/PAP, STATUS DS DO8
K991078 · Princeton BioMeditech Corp. · Apr 1999
ACCUSIGN DOA 8, ACCUSIGN DOA 8 PANEL, ACCUSIGN THC/OPI/COC/AMP/BZO/BAR/TCA/PCP, BIOSIGN DOA 8, BIOSIGN THC/OPI/COC/AMP/P
K983147 · Princeton BioMeditech Corp. · Sep 1998
MODIFIED LABELING FOR TOXI-LAB THC SCREEN
K875182 · Marion Laboratories, Inc. · Jul 1988
TOXI-LAB CANNABINOID THC SCREEN
K831456 · Marion Laboratories, Inc. · Jun 1983