(17 days)
Syntron's DrugCheck X Multidrug Screening Device (the X may be replaced by 2. 3. 4. 5. 6. 7. or 8) is a holder for up to eight rapid, qualitative, competitive binding immunoassay strips for the detection of drugs of abuse in urine at the SAMHSA designated GC/MS cutoff levels. The test strips available for inclusion in the DrugCheck X are Amphetamine, Methamphetamine, Benzodiazepine, Barbiturates, Cocaine, Marijuana (THC), Opiates, and Phencyclidine (PCP). The tests provide only preliminary data which should be confirmed by other methods such as gas chromatography/mass spectrophotometry (GC/MS). Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated6. Syntron's QuikStrip DrugCheck X Multidrug Screening Device is not intended to monitor drug levels, but only to screen urines for the presence of specific drugs of abuse and their metabolites.
Syntron's DrugCheck X Multidrug Screening Device (X is replaced by 2, 3, 4, 5, 6, 7, or 8) consists of two to eight (2-8) individual chromatographic absorbent devices in which the drug or drug metabolites in the sample compete with a drug conjugate immobilized on a porous membrane support for the limited antibody sites for each drug. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the free drug in the specimen forming an antibody:antigen complex. This complex, different for each drug, competes with immobilized antigen conjugate in the positive reaction zone and will not produce a magenta color band when the drug is above the detection level specified by SAMHSA for GC/MS. Unbound dye conjugate binds to the reagent in the control zone, producing a magenta color band, demonstrating that the reagents and device are functioning correctly. Each of the test strips in the holder functions independently and is read independently.
The provided text describes a 510(k) submission for the "QuikStrip DrugCheck X Multidrug Screening Device" by Syntron Bioresearch, Inc. This device is a strip holder for multiple immunoassay strips designed to detect drugs of abuse in urine.
Here's an analysis of the provided information against your requested criteria:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state specific acceptance criteria (e.g., a predefined sensitivity or specificity threshold). However, it implies the acceptance criterion is that the device's performance should not be significantly different from established methods like Emit II or GC/MS.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Inappropriate reactions/interference | No observations of inappropriate reactions or interference between tests | No observations of inappropriate reactions or interference in in-house testing. Clinical trial of 565 samples revealed no inappropriate reactions or interference. |
| Statistical difference from reference methods (Emit II, GC/MS) | Not significantly different | Not significantly different from those obtained by either Emit II or GC/MS (non-parametric statistical methods). |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: 565 clinical samples.
- Data Provenance: Clinical samples (prospective, as it's a "clinical trial"). The country of origin is not explicitly stated, but the company is located in Carlsbad, California, USA, suggesting the data is likely from the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth.
4. Adjudication method for the test set
The document does not describe an adjudication method. It states that "All positive samples by either screening method were confirmed by GC/MS," implying GC/MS served as the definitive reference method, not an adjudicated consensus.
5. 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 as the device is a diagnostic test kit for drugs of abuse, not an AI-assisted diagnostic tool that requires human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is a standalone diagnostic device. The results (color bands) are read directly from the strips without an intermediate algorithm or human-in-the-loop interpretation being evaluated in the customary sense of an AI/human reader study. The "reading" of the strip is a direct visual assessment.
7. The type of ground truth used
- For positive samples: Gas Chromatography/Mass Spectrophotometry (GC/MS) was used for confirmation. This is a highly accurate and widely accepted gold standard for drug detection.
- For negative samples: The document doesn't explicitly state how negative ground truth was established, but typically this would also involve GC/MS or a panel of known negative samples.
8. The sample size for the training set
The document does not mention a separate "training set" in the context of machine learning. This is a traditional immunoassay device, not an AI/ML-based system that would typically have a distinct training and test set. In-house testing for interference and inappropriate reactions would have been part of the development and initial validation, but not a "training set" as understood in AI studies.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set as defined in AI/ML contexts. For the "in-house testing" mentioned, ground truth would have been established through controlled spiking of samples with known drug concentrations and confirmation with GC/MS.
§ 862.3250 Cocaine and cocaine metabolite test system.
(a)
Identification. A cocaine and cocaine metabolite test system is a device intended to measure cocaine and a cocaine metabolite (benzoylecgonine) in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of cocaine use or overdose.(b)
Classification. Class II (special controls). A cocaine and cocaine metabolite 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).