FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard is a rapid drug screening test designed to qualitatively detect the presence of drugs and drug metabolites in human urine at the following cut-off concentrations:

Test	Calibrator	Cut-off level
Marijuana (THC)	Delta-9-THC-COOH	50 ng/mL
Cocaine (COC)	Benzoylecgonine	300 ng/mL
Amphetamine (AMP)	D-Amphetamine	1000 ng/mL
Methamphetamine (MET)	D-Methamphetamine	1000 ng/mL
Morphine 2000 (MOP)	Morphine	2000 ng/mL
Barbiturates (BAR)	Secobarbital	300 ng/mL
Benzodiazepines (BZO)	Oxazepam	300 ng/mL
Methylenedioxymethamphetamine (MDMA)	3,4-Methylenedioxymethamphetamine	500 ng/mL
Methadone (MTD)	Methadone	300 ng/mL
Oxycodone (OXY)	Oxycodone	100 ng/mL
Phencyclidine (PCP)	Phencyclidine	25 ng/mL
Buprenorphine(BUP)	Buprenorphine	10ng/mL
2-ethylidene-1, 5-dimethyl-3,	2-ethylidene-1, 5-dimethyl-3,	300 ng/mL
3-diphenylpyrrolidine(EDDP)	3-diphenylpyrrolidine
Morphine(MOP300)	Morphine	300 ng/mL
Propoxyphene(PPX)	Propoxyphene	300 ng/mL
Tri-cyclic Antidepressants (TCA)	Nortriptyline	1000 ng/mL

The tests contain two formats:1) Test Cup and 2) Test Dipcard. The tests may be configured as single drug tests in any combination of the drug analytes listed in the table above up to a maximum of 15 analytes. Only one cutoff concentration will be included per analyte per device. The tests are intended for in vitro diagnostics use. They are intended for prescription use including point of care sites and over-the-counter use.

The tests will vield preliminary positive results when prescription drugs Barbiturates. Benzodiazenine, Methadone, Propoxyphene or Tricyclic Antidepressants are ingested, even at or above there are no unformly recognized drug levels for Barbiturates, Buprenorphine, Benzodiazepine, Propoxyphene and Tricyclic Antidepressants in urine.

This assay provides only a preliminary analytical test result. Gas Chromatography Mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result. particularly when preliminary positive results are indicated.

Device Description

Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard are competitive binding, lateral flow immunochromatographic assays for qualitatively the detection of Amphetamine, Barbiturates, Buprenorphine, Benzodiazepines, Cocaines, 2-ethylidene-1, 5-dimethyl-3, 3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Methamphetamine, Morphine300, Morphine2000, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Tri-cyclic Antidepressants, Marijuana and their metabolites ( specifically THC ) at or above the cut-off levels as indicated. The tests can be performed without the use of an instrument. Test Cup and Test Dipcard use identical test strips made with same chemical formulation and manufacturing procedures.

AI/ML Overview

Here's an analysis of the acceptance criteria and study findings for the "Rapid Single/Multi-drug Test Cup, Rapid Single/Multi-drug Test Dipcard" device, based solely on the provided text:

This document is a 510(k) Premarket Notification summary to the FDA, indicating that the device is seeking clearance based on substantial equivalence to a legally marketed predicate device, not necessarily showcasing comprehensive clinical trials for novel devices. Therefore, the "study" described focuses on demonstrating equivalence rather than proving novel clinical utility with large-scale, multi-reader, or outcomes-based studies.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria are based on the ability to qualitatively detect specific drugs and their metabolites in human urine at predefined cut-off concentrations. The performance data demonstrates agreement with these cut-off concentrations, indicating the device meets the intended detection capability.

Table of Acceptance Criteria and Reported Device Performance (Specificity and Sensitivity implicitly)

For each drug, the acceptance criteria are to correctly identify negative samples and positive samples relative to the specified cut-off. The performance is reported in terms of the number of positive/negative results at various concentrations around these cut-offs during precision and accuracy studies.

Precision Study (Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC)

The precision study aimed for accurate detection at concentrations:

0 ng/mL: All negative
-75% cutoff: All negative or predominantly negative
-50% cutoff: All negative or predominantly negative
-25% cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
Cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
+25% cutoff: Mixture of positive and negative, demonstrating sensitivity around the cut-off
+50% cutoff, +75% cutoff, +100% cutoff: All positive or predominantly positive

Observed Performance (Summarized from Precision Tables)

For all drugs tested (AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC) across three lots for both the Test Cup and Test Dipcard:

At 0 ng/mL, -75% cutoff, and -50% cutoff: All (or overwhelmingly almost all) reported results were negative. This indicates good specificity below the cutoff.
At +50% cutoff, +75% cutoff, and +100% cutoff: All (or overwhelmingly almost all) reported results were positive. This indicates good sensitivity above the cutoff.
At -25% cutoff, cutoff, and +25% cutoff: A mixed distribution of positive and negative results was consistently observed, demonstrating the device's ability to differentiate samples around the cut-off concentration, as expected for a qualitative assay. For instance, at the exact cutoff, typically around 30-40 positive and 20-30 negative results were seen out of 60 determinations per lot, for most analytes.

Accuracy Study (Clinical Specimens - Example for AMP, BAR, BUP, BZO, COC, EDDP, MDMA, MET, MOP300, MOP2000, MTD, OXY, PCP, PPX, TCA, THC)

The accuracy study categorizes samples into five groups based on GC/MS or HPLC reference:

Drug free
Less than half the cutoff
Near cutoff negative (between 50% below cutoff and cutoff)
Near cutoff positive (between cutoff and 50% above cutoff)
High positive (greater than 50% above cutoff)

The acceptance criteria here are that results from the Rapid Multi-drug Test Cup/Dipcard should align with the GC/MS or HPLC classifications.

Observed Performance (Summarized from Accuracy Tables)

For both the Test Cup and Test Dipcard:

Drug-free, Less than half the cutoff, Near Cutoff Negative samples: Overwhelmingly resulted in negative reports from the device. A very small number of "false positives" (e.g., 1 or 2 positive results in the "Near Cutoff Negative" category for some drugs) were noted, and some "false negatives" for Buprenorphine, Morphine, Methadone, Oxycodone, TCA, and THC in the "Near Cutoff Negative" or "Near Cutoff Positive" categories when compared to the reference methods. The "Analysis of Discordant Results" section details these specific discrepancies.
Near Cutoff Positive and High Positive samples: Overwhelmingly resulted in positive reports from the device. Similar to above, a very small number of discordant results (e.g., some "Near Cutoff Positive" samples were reported negative by the device) were observed, which are explicitly detailed in the "Analysis of Discordant Results" tables.

Overall Conclusion on Acceptance Criteria: The studies presented generally demonstrate that the device performs as expected for a qualitative immunoassay, showing good agreement with GC/MS/HPLC results for samples significantly above or below the cut-off. The mixed results near the cut-off are typical for such tests.

Study Details

Sample size used for the test set and the data provenance:
- Precision Study: For each drug, there were 9 concentrations tested. For each concentration, 60 determinations were made (3 lots x 3 runs/day x 10 days = 90 determinations per concentration, but the table indicates 60 determinations per lot for each concentration, which suggests (2 operators * 3 aliquots tested per lot per day = 6 determinations per lot per day) * 10 days leads to 60 determinations per lot). With 16 drugs, this means roughly 16 x 9 x 60 = 8,640 determinations for the precision study (excluding the implicit number of lots).
- Accuracy Study (Clinical Samples): 80 clinical urine specimens per drug were used for both the Multi-drug Test Cup and Multi-drug Test Dipcard. With 16 drugs, this amounts to 16 x 80 = 1,280 samples per device format (Cup and Dipcard), so a total of 2,560 unique clinical specimens.
  - Data Provenance: The document does not specify the country of origin but states "Clinical urine specimens." It also states these were "retrospective" as they were analyzed by GC/MS/HPLC prior to testing with the device, and then retrospectively analyzed against the device results. The absence of details on where these clinical samples were collected typically means their origin is unknown or not considered relevant for this type of submission (often laboratory-sourced for drug testing evaluations).
- Lay User Study: 1720 lay users participated. Each participant performed 1 test. Urine samples were prepared at 0, +/- 50% cutoff, +/- 25% cutoff, and +100% cutoff. This study does not explicitly state the number of unique urine samples used but rather the number of user interactions with a test sample. For each drug and each concentration, there were 10 or 30 or 360 determinations across two lots (one for Cup, one for Dipcard, it seems implied).
  - Data Provenance: Not specified, but involved "lay users" performing tests, implying a prospective collection for this specific study.
- Interference Study: For each drug, 4 concentrations (0, -50% cutoff, +50% cutoff, +100% cutoff), 3 lots, and 15 determinations per lot per concentration. This amounts to 16 x 4 x 3 x 15 = 2,880 determinations.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Ground Truth Method: For the accuracy studies, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC). These are analytical chemistry "gold-standard" methods, not expert human interpretation.
- Number/Qualifications of Experts: Not applicable in the context of GC/MS or HPLC as ground truth. The results are based on analytical measurements, not human interpretation of images or observations.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- No formal adjudication method is described for establishing ground truth, as the ground truth relies on quantitative analytical methods (GC/MS, HPLC) rather than subjective human assessment.
- For the precision study, results were based on multiple determinations (e.g., 60 per lot per concentration), and for the lay user study, the "agreement" was calculated based on the collective results of the lay users against the known spiked concentrations. Discordant results in the accuracy study are individually listed, implying a comparison against the GC/MS/HPLC result without further adjudication panels described for the device's outcome.
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:
- No MRMC comparative effectiveness study was performed or described. This device is a rapid diagnostic test (Test Cup/Dipcard) for drug screening, not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improving with AI vs without AI assistance" does not apply to this specific device. The closest equivalent is the "Lay User Study," which assesses how well lay users can interpret the test independently using the provided instructions. Their agreement rates for correctly classifying samples are provided.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, in essence, standalone performance was assessed in the "Precision" and "Accuracy" studies if "standalone" is interpreted as the device's intrinsic ability to detect drugs in controlled and clinical samples when read by trained operators. The device itself (the dipcard or cup) produces a visual qualitative result (lines appearing or not appearing), which is then read. The "precision study" and "accuracy study" data (Table 8.5, 8.6) represent this "algorithm only" (device only) performance when operated and interpreted by presumably trained personnel. The "Lay User Study" (Table 8.7) assesses reading by an untrained human-in-the-loop, demonstrating usability rather than optimal device performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth for the accuracy studies was established by analytical chemistry methods: Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC). These methods provide quantitative measurements of drug concentrations, which are considered the definitive "ground truth" for drug screening device validation. For spiked samples in precision, lay user, and interference studies, the ground truth was the known spiked concentration of the drug.
The sample size for the training set:
- This document describes a 510(k) submission, which is for a traditional in-vitro diagnostic device (a rapid test cup/dipcard with reagent strips). There is no "training set" in the context of machine learning or AI models, as this device does not utilize such technologies. The studies described are for validation and performance assessment of the physical chemical assay.
How the ground truth for the training set was established:
- As there is no "training set" in the AI/ML sense, this question is not applicable to the device described. The studies involve testing the device against samples with known drug concentrations (either spiked or determined by reference analytical methods) to evaluate its performance.

Summary

Regulation Number and Section

§ 862.3650 Opiate test system.

(a)
Identification. An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.(b)
Classification. Class II (special controls). An opiate 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).