BIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP

K082977 · Mk Bio, Inc. · LDJ · Aug 20, 2009 · Clinical Toxicology

Device Facts

Record IDK082977
Device NameBIONEXIA OPTICUP MULTI-STRIP DOA DIPSTICK TEST INTEGRATED CUP
ApplicantMk Bio, Inc.
Product CodeLDJ · Clinical Toxicology
Decision DateAug 20, 2009
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 862.3870
Device ClassClass 2

Indications for Use

The Bionexia OptiCup is a rapid chromatographic immunoassay for the qualitative and simultaneous detection of elevated levels of Marijuana, Cocaine, Phencyclidine, Morphine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline in human urine at or above the following concentrations: Marijuana 50 ng/mL, Cocaine 300 ng/mL, Phencyclidine 25 ng/mL, Morphine 2,000 ng/mL, Methamphetamine 1,000 ng/mL, Methadone 300 ng/mL, Amphetamine 1,000 ng/mL, Barbiturates 300 ng/mL, Benzodiazepines 300 ng/mL, Nortriptyline 1,000 ng/mL. The Bionexia OptiCup is used to obtain visual qualitative test results and is intended for healthcare professionals only. It is not intended for over the counter sale to non-professionals. This device provides only a preliminary analytical test result. A more specific alternative chemical method must be used in order to obtain a confirmed analytical test result. Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography Mass Spectrometry (LC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated.

Device Story

Bionexia OptiCup is an integrated urine collection and testing device for drugs of abuse. It utilizes lateral flow immunochromatographic test strips (1 to 10 per cup) housed within a plastic cup. The user collects a urine sample directly into the cup; the integrated dipstick assembly contacts the specimen. Results are read visually at 5 minutes. A positive result is indicated by the absence of a colored line in the test region; a negative result or levels below cutoff generate a colored line. A control line confirms proper sample volume and wicking. The device is intended for use in hospitals, clinics, workplace screening, and justice systems by healthcare professionals. It provides preliminary results; positive findings require confirmation via GC/MS or LC/MS. The integrated design allows for simultaneous collection, testing, and storage of the remaining unadulterated specimen for laboratory confirmation, streamlining the workflow for clinicians.

Clinical Evidence

No clinical data provided. The device relies on bench testing to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Lateral flow immunochromatographic assay. Integrated plastic cup housing 1-10 test strips. Visual readout. No instrumentation required. Qualitative detection based on competitive binding principle.

Indications for Use

Indicated for the qualitative detection of drugs of abuse in human urine specimens.

Regulatory Classification

Identification

A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds include delta-9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

Special Controls

*Classification.* Class II (special controls). A cannabinoid test system is not exempt if it is intended for any use other than employment or insurance testing or is intended for Federal drug testing programs. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9, provided the test system is intended for employment and insurance testing and includes a statement in the labeling that the device is intended solely for use in employment and insurance testing, and does not include devices intended for Federal drug testing programs (*e.g.,* programs run by the Substance Abuse and Mental Health Services Administration (SAMHSA), the Department of Transportation (DOT), and the U.S. military).

Predicate Devices

Submission Summary (Full Text)

{0} SPECIAL 510(k): Device Modification OIVD Review Memorandum (Decision Making Document is Attached) To: THE FILE RE: DOCUMENT NUMBER k082977 This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary): 1. The name and 510(k) number of the SUBMITTER'S previously cleared device. Applied DNA Technologies Inc ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels cleared under k061005 2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use). 3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for the addition of a plastic collection cup to the device to create an integrated test device. The integrated test device can be used for collecting the specimen and performing the tests at the same time. In addition, the submitter has changed the company name to MK Bio Inc. and the device name to Bionexia OptiCup DOA Test. 4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, and physical characteristics. 5. A Design Control Activities Summary which includes: a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied c) A declaration of conformity with design controls. The declaration of conformity should include: i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review. 6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices). The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.
Innolitics

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