(15 days)
The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid in vitro diagnostic (IVD) qualitative lateral flow immuno-chromatographic competitive urinary rapid in Thiro didinestion of Phencyclidine, analogs and metabolites (collectively: PCP) in human urine at the NIDA (National Institute on Drug Abuse) and SAMHSA (Substance Abuse and Mental at the Nizes (national motified of 25 ng PCP/ml. These IVD tests are intended for visual, qualitative screening, for professional use only, and are not intended for quantitative visual, qualifative Screening, Tor prorocolonial ass "Chily" and PCP Screen Tests for PCP provide only preliminary qualitative analytical data. A more specific quantitative alternative method must be used in order to obtain a confirmed analytical result. NIDA and SAMHSA have established gas chromatographic/mass spectrometry (GC/MS) as 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.
The Pan Probe Biotech LiveSure™ Phencyclidine Screen Test Card and Test Strip devices are rapid qualitative competitive chromatographic IVD immunoassays, in which a chemically labeled drug obligate competes for limited specific antibody binding sites. LiveSure™ PCP devices have a unique membrane pre-coated with a gold conjugate immunoassay indicator that is used is pre-labeled with specific monoclonal antibody from mouse directed against Indicator that is used to pro labora will opists of a membrane absorbent pad having a gold-probe-POr . Each rest othp and Toot ours control ontibody from mouse that is directed against PCP, Conjugate pre labolou with openits monecoated with a chemically modified PCP-conjugate as a and a chromatographio mombrare pro oats device has been layered with PCP-conjugate as a 11 capture reagent, while the Process Control region has been pre-coated with a first molledge and capture Teagent derived from goat. A pink colored anti-PCP monoclonal antibody-colloidal gold anabody reagent derivou from goal. A phe test strip. In the absence of PCP drug, analogs or conjugate paa is placed to sample, the pink colored antibody-colloidal gold conjugate moves chromatographically along with the urinary sample on the membrane by capillary action. Antibodycolloidal gold conjugate binds to PCP-drug conjugate, forming an antibody-antigen complex. This collondar gold conjugate appears as second visible pink colored band and captured reagent at the test region. Any PCP drug, analogs or metabolites that are present in sample urine act as the test region. Any PCP-drug conjugate at the test band region for limited PCP-antibody amigone, oomponing min-reloidal gold conjugate. When a sufficient concentration of urinary PCP blog, analogs or metabolites are present, these analytes block the limited antibody binding sites. This andy, and oge of measons of pink colored antibody-colloidal gold conjugate to the PCPblookugo binding provents d at the test band region. To serve as a procedural control, a pink colored arag control region will always appear regardless of the presence of PCP in urinary samples. band in a ountrol rogion will amays appear of an and while positive urine samples produce only one pink colored band.
Here's an analysis of the acceptance criteria and study detailed in the provided 510k submission for the LiveSure™ PHENECYCLINE (PCP) SCREEN TESTS:
Acceptance Criteria and Device Performance Study for LiveSure™ PHENECYCLINE (PCP) SCREEN TESTS
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on comparative performance against a predicate device (EMIT® II Assay) and a gold standard (GC/MS). While explicit "acceptance criteria" are not numerically stated in the provided text as pass/fail thresholds before the study, the reported performance against these benchmarks implicitly serves as the criteria for demonstrating substantial equivalence. The key performance metrics presented are agreement rates and accuracy.
| Performance Metric | Acceptance Criteria (Implicit) | LiveSure™ Device Performance (Card) | LiveSure™ Device Performance (Strip) | Predicate Device (EMIT® II) Performance |
|---|---|---|---|---|
| Agreement with GC/MS (Positive) | High agreement with GC/MS positive results. | 100% | 100% | Not reported explicitly in this row but context implies high. |
| Agreement with GC/MS (Negative) | High agreement with GC/MS negative results. | 97.2% | 97.2% | 98.1% |
| Agreement with EMIT® II (Positive) | High agreement with predicate device positive results. | 100% | 100% | N/A (predicate) |
| Specificity vs EMIT® II (Negative) | High agreement with predicate device negative results (specificity). | 99.0% | 99.0% | N/A (predicate) |
| Overall Accuracy vs GC/MS | High overall accuracy against GC/MS. | 98.0% (291/297) | 98.0% (291/297) | 99.3% (295/297) ** |
| Equivalency to Predicate (Overall) | "Equivalency" in performance to EMIT® II. | Deemed equivalent | Deemed equivalent | N/A (predicate) |
Note: The submission states "295/297 (99.3%) accuracy was obtained with EMIT®II". This implies that EMIT® II was also evaluated against the GC/MS standard, allowing for a three-way comparison.
2. Sample Size and Data Provenance
- Test Set Sample Size: 297 urine samples.
- Data Provenance: The text states "independent clinical testing of 297 urine samples". The country of origin is not explicitly stated, but the submission is for a US FDA 510(k), suggesting the testing likely involved samples relevant to the US population or a US-based independent laboratory. The data is retrospective, as it refers to "samples" being tested, not a live, ongoing collection for the study.
3. Number and Qualifications of Experts for Ground Truth
The text refers to an "independent laboratory" that performed GC/MS quantitative analysis. It does not specify the "number of experts" or their specific "qualifications" (e.g., years of experience for toxicologists performing GC/MS). However, GC/MS is a highly specialized analytical technique, and it is assumed that personnel in such a laboratory are qualified experts in toxicology and analytical chemistry.
4. Adjudication Method for the Test Set
The adjudication method for the test set was GC/MS (Gas Chromatography/Mass Spectrometry), which is the established "preferred confirmatory method" according to NIDA and SAMHSA for drug screening. There is no mention of a human consensus or "2+1, 3+1" type adjudication process for the drug assay results themselves; rather, GC/MS serves as the definitive gold standard.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This submission describes a diagnostic device (an in vitro diagnostic test for PCP in urine) rather than an imaging or clinical decision support AI tool that human readers would interact with. The "readers" here are the individuals who interpret the test strips/cards, but the study focuses on the device's accuracy against a gold standard and a predicate, not on how the device assists human interpretation or improves human reader performance in a clinical setting.
6. Standalone Performance Study
Yes, a standalone performance study was done. The described "independent clinical testing of 297 urine samples against LiveSure™ Phencyclidine Screen Test Card and Test Strip devices" and the calculation of agreement rates and overall accuracy against GC/MS directly demonstrates the standalone performance of the LiveSure™ devices (both card and strip formats) without human-in-the-loop assistance influencing the device's output. The device itself yields a qualitative positive/negative result.
7. Type of Ground Truth Used
The type of ground truth used was GC/MS (Gas Chromatography/Mass Spectrometry) quantitative results from an independent laboratory. This is a highly objective and recognized analytical gold standard for confirming the presence and quantity of substances like phencyclidine and its metabolites. Outcomes data or expert consensus (in the sense of clinical decision-making) were not the primary ground truth for the device's analytical performance.
8. Sample Size for the Training Set
The submission does not explicitly state the sample size for a training set. The described testing against 297 samples is presented as a validation or clinical evaluation set. For IVD devices, a "training set" in the context of machine learning (AI) is usually not applicable in the same way as for complex algorithms. However, in-house testing against a predicate device (EMIT® II Assay) is mentioned, which may have involved internal development and optimization, but the specific sample size for such internal work is not provided.
9. How the Ground Truth for the Training Set Was Established
As no explicit "training set" with separate ground truth establishment is described in the provided text, this question cannot be fully answered. If there was an internal training or development phase, the methods for establishing ground truth for those samples are not detailed. It is highly probable that internal ground truth would have also relied on GC/MS or other established analytical methods to ensure the device was developed to accurately detect PCP.
N/A