Cleared Special

K082977 - BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

K082977 is an FDA 510(k) clearance for BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTI..., manufactured by Mk Bio, Inc.. The device is a Class 2 Toxicology device with product code LDJ cleared through the Special 510(k) pathway after a 318-day FDA review.

K082977 · Mk Bio, Inc. · Toxicology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
318d
Days
Class 2
Risk

K082977 is an FDA 510(k) clearance for the BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP. Classified as Enzyme Immunoassay, Cannabinoids (product code LDJ), Class II - Special Controls.

Submitted by Mk Bio, Inc. (San Diego, US). The FDA issued a Cleared decision on August 20, 2009 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K082977

510(k) Number K082977 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2008
Decision Date August 20, 2009
Days to Decision 318 days
Submission Type Special
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
231d slower than avg
Panel avg: 87d · This submission: 318d
Pathway characteristics
Modification to existing cleared device.

LDJ Device Classification - Class 2, Special Controls

Product Code LDJ Enzyme Immunoassay, Cannabinoids
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 - LDJ Enzyme Immunoassay, Cannabinoids

All 149
Devices cleared under the same product code (LDJ) and FDA review panel - the closest regulatory comparables to K082977.
CANNABINOIDS URINE TEST
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CANNABINOID ASSAY AND THE RANDOX CANNABINOID CALIBRATOR/ CONTROL SET
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THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY
K101744 · Microgenics Corp. · Apr 2011
BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
K080467 · Applied Dna Technologies, Inc. · Nov 2008
AMEDICHECK DRUG SCREEN THC, COC, OPI, AMP, MET, PCP, MDMA,BAR, BZ
K080872 · Amedica Biotech, Inc. · Aug 2008
VITROS CHEMISTRY PRODUCTS THC REAGENT, CALIBRATOR KIT 30, FS CALIBRATOR 1, AND DAT PERFORMANCE VERIFIERS I, II, III, IV
K063164 · Ortho-Clinical Diagnostics, Inc. · Dec 2006
K082977 · BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
Download PDF FDA Summary Mk Bio, Inc.