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

CR3 Keyless Split Sample Cup Morphine-Oxazepam is a rapid test for the qualitative detection of Morphine (a drug in the opiate class) and Oxazepam(a drug in the benzodiazepine class) in human urine at a cutoff concentration of 2000ng/mL and 300ng/mL, respectively.

The tests may yield preliminary positive results even when prescription drugs including Morphine and Oxazepam are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of these drugs. There are no uniformly recognized cutoff concentration levels for morphine and oxazepam in urine. The test provides only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. It is intended for over-the-counter and for prescription use.

Device Description

Immunochromatograph assays for Opiate and Benzodiazepines Urine Tests use a lateral flow, one step system for the qualitative detection of Morphine and Oxazepam in human urine. Each assay uses a monoclonal antibody-dye conjugate against drugs with gold chloride and fixed drug-protein conjugates and anti-mouse IgG polyclonal antibody in membranes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Criteria	Acceptance Range (Implicit)	Reported Device Performance (Morphine)	Reported Device Performance (Oxazepam)
Precision	Should consistently detect positive samples above cutoff and negative samples below cutoff. A small number of discordant results near the cutoff may be acceptable within a certain range.	For samples at -25% cut-off, all 50 tests were negative (0+). At +25% cut-off, all 50 tests were positive (50+/0-).
For samples at the exact cutoff, Lot W11510201CU5 showed 43 positive and 7 negative results (86% positive). Lot W11510202CU5 showed 44 positive and 6 negative results (88% positive). Lot W11510203CU5 showed 43 positive and 7 negative results (86% positive).	For samples at -25% cut-off, all 50 tests were negative (0+). At +25% cut-off, all 50 tests were positive (50+/0-).
For samples at the exact cutoff, Lot W11510201CU5 showed 43 positive and 7 negative results (86% positive). Lot W11510202CU5 showed 43 positive and 7 negative results (86% positive). Lot W11510203CU5 showed 42 positive and 8 negative results (84% positive).
Stability	Stable for a specified duration at certain temperatures.	Stable at 4-30°C for 18 months.	Stable at 4-30°C for 18 months.
Cut-off Values	Device must employ specific cutoff concentrations for detection.	Morphine: 2000 ng/mL	Oxazepam: 300 ng/mL
Interference	Should show no interference from common compounds at specified concentrations.	Numerous compounds listed show no interference at 100 µg/mL.	Numerous compounds listed show no interference at 100 µg/mL.
Specificity/Cross-Reactivity	Should accurately detect the target drug and demonstrate anticipated cross-reactivity with related compounds.	- Morphine: 100% at 2000 ng/mL

Codeine: 100% at 2000 ng/mL
Ethylmorphine: 40% at 5000 ng/mL
(and other cross-reactive compounds listed) | - Oxazepam: 100% at 300 ng/mL
Alprazolam: 150% at 200 ng/mL
Clobazam: 300% at 100 ng/mL
(and other cross-reactive compounds listed) |
| Effect of Urine Density | Test results should not be affected by varying urine densities. | No effect on test results for samples with density ranges (1.000-1.035). | No effect on test results for samples with density ranges (1.000-1.035). |
| Effect of Urine pH | Test results should not be affected by varying urine pH levels. | No interference for samples with pH range of 4 to 9. | No interference for samples with pH range of 4 to 9. |
| Comparison Study (Professional Users) | Device results should show good agreement with GC/MS results, especially for samples significantly above or below the cutoff. Minor discrepancies expected near cutoff. | For Morphine:
Negative by GC/MS (all categories): 100% negative results by all professional users.
High Positive by GC/MS: 100% positive results by all professional users.
Near Cutoff Negative: 2-3 positive results observed among 10-test sets for each viewer.
Near Cutoff Positive: 1-2 negative results observed among 20-test sets for each viewer. | For Oxazepam:
Negative by GC/MS (all categories): 100% negative results by all professional users.
High Positive by GC/MS: 100% positive results by all professional users.
Near Cutoff Negative: 2-3 positive results observed among 30-test sets for each viewer.
Near Cutoff Positive: 1-4 negative results observed among 20-test sets for each viewer. |
| Lay-User Study | High percentage agreement with GC/MS results, especially for samples significantly above or below the cutoff. Some discrepancy near cutoff is expected. | For Morphine:
-100%, -75%, -50% cut-off: 100% agreement.
-25% cut-off: 90% agreement.
+25% cut-off: 85% agreement.
+50%, +75% cut-off: 100% agreement. | For Oxazepam:
-75%, -50% cut-off: 100% agreement.
-25% cut-off: 85% agreement.
+25% cut-off: 85% agreement.
+50%, +75% cut-off: 100% agreement. |

Study Details:

Test Set Sample Size and Data Provenance:
- Precision Study: For each concentration level (-100%cut off, -75%cut off, -50%cut off, -25%cut off, +25%cut off, +50%cut off , +75%cut off and +100%cut off), tests were performed two runs per day for 25 days with three different lots of devices. This means 50 tests per concentration per lot for a total of 450 tests per lot for 9 concentrations. With 3 lots, this amounts to 1350 tests for Morphine and 1350 tests for Oxazepam in the precision study.
- Comparison Studies (Professional Users): 80 unaltered clinical samples in total (40 negative and 40 positive) were used for each drug (Morphine and Oxazepam). The provenance is "in-house," implying these were likely collected for the purpose of the study. The text does not specify the country of origin, but the company is based in Guangzhou, P.R. China. The samples were "clinical samples," and the study compared device results to GC/MS, making it a prospective assessment within the study's scope, though the collection method of the initial clinical samples isn't fully detailed.
- Lay-User Study: 260 lay persons participated. For each drug, urine samples were prepared at 7 different concentrations, with 20 samples per concentration. This means 140 samples were tested for Morphine and 140 samples were tested for Oxazepam within this study using lay users. The samples were "prepared" by spiking drug-free pooled urine, indicating controlled, laboratory-prepared samples. Data provenance is implied as "in-house."
Number of Experts and Qualifications:
- Comparison Studies (Professional Users): "three laboratory assistants with relevant experience" were used. Specific qualifications (e.g., number of years of experience, specific certifications) are not provided beyond "relevant experience."
- Lay-User Study: One "lay person" was also included in the comparison study for context, but not to establish ground truth.
Adjudication Method:
- For the precision study and lay-user study, the comparison for correctness was directly against the known prepared concentrations.
- For the comparison studies with professional users, the device results were compared directly against independently confirmed GC/MS results, meaning GC/MS served as the definitive ground truth, and no explicit expert adjudication method (like 2+1 or 3+1) was used between the viewers. The viewers independently interpreted the device results, and these were then compared to the GC/MS.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was explicitly performed to measure the effect size of how much human readers improve with AI vs. without AI assistance. This device is a rapid test kit, not an AI-assisted diagnostic tool.
Standalone (Algorithm Only) Performance:
- This is not applicable as the device is a lateral flow immunoassay, a chemical test, and does not involve an algorithm or AI. The results are visually interpreted.
Type of Ground Truth Used:
- Precision and Lay-User Studies: Ground truth was established by known concentrations of the drugs (spiked samples), confirmed by GC/MS.
- Comparison Studies (Professional Users): Ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry) results for unaltered clinical samples. GC/MS is considered the "preferred confirmatory method" and is an objective chemical analysis.
Training Set Sample Size:
- The document does not explicitly mention a "training set" in the context of machine learning or algorithm development, as this is a chemical diagnostic device. The performance characteristics describe validation studies, not training data for an algorithm.
How Ground Truth for Training Set was Established:
- Not applicable, as there is no "training set" for an algorithm. The development of the immunochromatographic assay itself would involve laboratory testing and optimization, but this wouldn't be referred to as establishing ground truth for a training set in the AI sense.

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).