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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:

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.

Configurations of the Bionexia OptiCup can consist of any combination of the above listed drug analytes.

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.

Bionexia OptiCup is derived from a previously FDA-cleared device, ADT's ACCUSTEP Single and Multi-Strip Cassette/Dipstick DOA Screen Panels (K061005).

The unmodified test is made of various number of single drug-of-abuse (DOA) test strips (from 1 to 10 strips) placed in an open faced housing. These test strips are fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. When running the test, the dipping end of the test panel is dipped into urine sample and test results read at 5 minutes.

The test strips used in Bionexia OptiCup are made in the exact same manner as the strips used in the cleared ACCUSTEP Single and Multi-Strip Dipstick DOA Screen Panels from one to ten single test strips placed in an open-faced housing inside a plastic cup. In Bionexia OptiCup, these test strips are assembled and fixed in position with an adhesive label covering over the absorbent end of the test card with dipping end protruding. The dipstick assembly is then sealed, (integrated) into a plastic urine cup, which also serves as a urine collection and specimen delivering device to run the test in one integrated device.

Bionexia OptiCup is a user-friendly modification of the unmodified device. To use an unmodified device, user has to collect urine sample in a container, tear open the dipstick device pouch, take off the device cover, dip the device into urine sample and hold it for 5-10 seconds, cover the dipstick device cover, lay device flat and wait for 5 minutes to read the preliminary qualitative test results. To use a modified device, user can open the cup pouch and take out the integrated OptiCup, simultaneously collect, dispense urine for dipping, run the test and obtain preliminary qualitative test results in 5 minutes. The leftover urine specimen in the cup, which is not adulterated or tampered with in any way, can be sent in to a toxicology lab for confirmation especially when a presumptive positive test result is obtained. This modified device allows user to administrate multiple drug test from urine specimen collection, testing, and result confirmation with one single device.

Bionexia OptiCup presents an ideal and convenient for various testing environments such as hospitals, clinics, workplace pre-employment screening, justice system or court-ordered compliance monitoring and random drug testing. This integrated Cup is designed to accompany available line of drugs of abuse tests from ADT. Customers can choose any combination of the cleared drug of abuse tests and integrated into this cup.

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 Nortriotyline in human urine at or above the following concentrations:

These tests can be performed without the use of an instrument.

A positive urine specimen will not generate a colored-line for the specific drug tested in the designated test region. A negative urine specimen or a urine specimen containing Marijuana, Cocaine, Phencyclidine, Methamphetamine, Methadone, Amphetamine, Barbiturates, Benzodiazepines and Nortriptyline below the designated cutoff levels will generate a colored line in the designated test region for the drug. To serve as a procedural control, a colored-line will always appear at the control region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Here's an analysis of the acceptance criteria and study information for the Bionexia OptiCup, based on the provided text:

Based on the provided 510(k) summary, the device is a qualitative drug screening immunoassay, and as such, the "performance" is typically measured by its ability to correctly identify the presence or absence of the target analytes (drugs) at or above specified cutoff concentrations. The document does not explicitly state "acceptance criteria" in a numerical, performance-based format (e.g., sensitivity > X%, specificity > Y%), which is common for descriptive performance summaries of qualitative tests. Instead, it defines the intended performance by listing the cutoff concentrations for each drug and implies that the device should accurately detect drugs at or above these levels and not detect them below these levels.

The study that proves the device meets the acceptance criteria is described as a modification of a previously FDA-cleared device. The 510(k) process for a modified device often relies heavily on demonstrating substantial equivalence to the predicate device, especially if the modification is primarily in form factor (as is the case here, from a dipstick to an integrated cup). The provided text describes the changes and claims equivalence in the test strips themselves.

Here's the breakdown of the information you requested:

Acceptance Criteria and Reported Device Performance

The document defines the performance by the cutoff concentrations for each drug. The device's "performance" is its ability to qualitatively detect these drugs at or above these specific concentrations. The provided text does not include quantitative performance metrics like sensitivity, specificity, or accuracy percentages, which are often reported for diagnostic devices. Instead, it implicitly states that the device is intended to detect at these cutoffs.

(Note: The "Reported Device Performance" column reflects the intended qualitative claim based on the cutoff concentrations provided. The document does not provide a separate table of actual measured performance results (e.g., sensitivity, specificity tables) against these cutoffs for the Bionexia OptiCup specifically, but rather relies on the equivalence to the predicate device.)

Study Details

1. Sample size used for the test set and the data provenance:
   The provided text does not specify the sample size for a test set or the data provenance (e.g., country of origin, retrospective/prospective) for this specific device's validation. The submission focuses on the Bionexia OptiCup being a "user-friendly modification" of a previously cleared device (K061005), implying that much of the core performance data comes from the predicate device. For a modified device with largely unchanged core technology (the test strips themselves), detailed new performance studies on a large test set might not be explicitly detailed in the 510(k) summary if the substantial equivalence argument is strong.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the given text. For drug screening tests, ground truth is typically established by more specific confirmatory laboratory methods rather than expert consensus.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not provided in the given text. Adjudication methods are typically used in imaging or subjective interpretation tasks, not usually for objective chemical assays like this.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   This is not applicable to this device. The Bionexia OptiCup is a rapid chromatographic immunoassay, not an AI-powered diagnostic device, and does not involve human "readers" in the context of MRMC studies typical for AI in radiology. The results are visual and qualitative, read directly from the test strip.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   This is not applicable as it is not an algorithm or AI device. The device is a standalone chemical assay. The performance is the "standalone" performance of the assay itself.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   For drug screening tests, the established ground truth typically involves Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography Mass Spectrometry (LC/MS). The text explicitly states: "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." This indicates that these laboratory methods are considered the gold standard for confirmation.

7. The sample size for the training set:
   The document does not specify a "training set" sample size. This term is primarily relevant for machine learning algorithms. For an immunoassay, the development typically involves assay optimization and validation, not "training" in the ML sense.

8. How the ground truth for the training set was established:
   As there is no "training set" in the context of machine learning for this device, this question is not applicable. Assay development and validation would use samples spiked with known concentrations of analytes or clinically collected samples confirmed by a reference method (like GC/MS or LC/MS), but these aren't referred to as a "training set."

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