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510(k) Data Aggregation
(51 days)
Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse.
Abuscreen ONLINE Cocaine Metabolite is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzoylecgonine, the primary metabolite of cocaine in human urine on automated clinical chemistry analyzers at a cutoff concentrations of 300 ng/mL. Semiquantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program. Measurements obtained by this device are used in the diagnosis of cocaine use or abuse. The proposed Abuscreen ONLINE Cocaine Metabolite test kit is specifically intended for use on the Hitachi 917 Analyzer and future similar analyzer models. It was adapted from the currently marketed Abuscreen ONLINE Cocaine Metabolite test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Cocaine Metabolite kit; although the labeling and packaging have been modified for use on the Hitachi 917 Analyzer. This modified test kit is not a replacement to the currently marketed kit. The Hitachi 917 Analyzer System is a fully automatic, computer-controlled system for clinical chemistry. It was conceived for both quantitative and qualitative in vitro determination using a large variety of tests for analysis, e.g. in serum and urine. Integrated in the system is an ion-selective unit for determination of electrolytes. The throughput per hour is 800 tests for clinical chemistry (1200 with electrolytes). The system consists of the analyzer which performs all functions required for fully automatic sample and test processing. Beginning with the automatic recording of patient samples - provided that they are supplied in barcode-labeled vessels - up to the photometric measurement and results transmission to the computer unit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Abuscreen ONLINE® Cocaine Metabolite device:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a separate section. However, by comparing the proposed device's performance to the predicate device, we can infer that the acceptance criteria for the new device align with demonstrating substantial equivalence to the predicate, particularly in the key performance characteristics. The table below summarizes the reported performance for the new device. The implied acceptance criteria are that the new device's performance should be comparable to or better than the predicate's, considering the specified cutoff levels.
| Performance Characteristic | Acceptance Criteria (Implied, based on Predicate) | Reported Device Performance (Proposed: Abuscreen ONLINE Cocaine for Hitachi 917) |
|---|---|---|
| Precision Qualitative (300 ng/mL Cutoff): | ||
| >95% negative at 225 ng/mL | >95% negative at 240 ng/mL | >95% negative at 225 ng/mL |
| >95% positive at 375 ng/mL | >95% positive at 360 ng/mLL | >95% positive at 375 ng/mL |
| Within Run Precision (Qualitative - OD): | Similar CV% to predicate (not explicitly stated, but implied goal is low CV%) | |
| 150 ng/mL (Mean OD, CV%) | Not explicitly stated | 6245, 1.3 % |
| 225 ng/mL (Mean OD, CV%) | Not explicitly stated | 4436, 1.0 % |
| 300 ng/mL (Mean OD, CV%) | Not explicitly stated | 2746, 1.1 % |
| 375 ng/mL (Mean OD, CV%) | Not explicitly stated | 1907, 1.4 % |
| 450 ng/mL (Mean OD, CV%) | Not explicitly stated | 1708, 1.9 % |
| Day-to-Day Precision (Qualitative - OD): | Similar CV% to predicate | |
| 150 ng/mL (Mean OD, CV%) | Not explicitly stated | 6178, 1.7 % |
| 225 ng/mL (Mean OD, CV%) | Not explicitly stated | 4379, 2.0 % |
| 300 ng/mL (Mean OD, CV%) | Not explicitly stated | 2696, 2.4 % |
| 375 ng/mL (Mean OD, CV%) | Not explicitly stated | 1873, 2.9 % |
| 450 ng/mL (Mean OD, CV%) | Not explicitly stated | 1661, 2.5 % |
| Precision Quantitative (300 ng/mL Cutoff): | Similar CV% to predicate (e.g., <= 4% for 150ng/mL, <= 2% for 225, 300 ng/mL) | |
| Within Run (Conc. ng/mL, CV%): | ||
| 150 ng/mL | 215, 2% (for 200 ng/mL predicate) | 154, 1.1% |
| 225 ng/mL | 300, 2% (for 300 ng/mL predicate) | 230, 1.1% |
| 300 ng/mL | 340, 2% (for 340 ng/mL predicate) | 301, 0.9% |
| 375 ng/mL | Not explicitly stated | 407, 0.6% |
| 450 ng/mL | Not explicitly stated | 441, 0.6% |
| Day-to-Day (Conc. ng/mL, CV%): | ||
| 150 ng/mL | 211, 4% (for 200 ng/mL predicate) | 150, 2.9% |
| 225 ng/mL | 298, 2% (for 300 ng/mL predicate) | 228, 1.4% |
| 300 ng/mL | 336, 2% (for 340 ng/mL predicate) | 300, 1.0% |
| 375 ng/mL | Not explicitly stated | 406, 0.7% |
| 450 ng/mL | Not explicitly stated | 441, 0.7% |
| Accuracy (300 ng/mL Cutoff): | 100% agreement with confirmed positives (predicate had 98 positive, 0 negative) | N=50 Confirmed Pos. -> 50 Pos., 0 Neg. (100% agreement) |
| Limit of Detection (LoD): | < 5 ng/mL (predicate) | 26 ng/mL |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions a sample size for an Accuracy study:
- Test Set Sample Size: N=50 Confirmed Positives for the proposed device, and N=98 Confirmed Positives for the predicate device.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, given it's an in vitro diagnostic for urinary drug screening, it's typically performed with human urine samples in a laboratory setting. The specific source or whether it was retrospective or prospective is not detailed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document refers to "Confirmed Positives" for the Accuracy study. This implies that the ground truth was established by confirmatory methods, likely an independent, highly accurate analytical technique (e.g., GC/MS or LC/MS). The document does not mention:
- The number of experts.
- The qualifications of those experts (e.g., radiologist with 10 years of experience). This is expected, as medical imaging experts are not relevant for establishing ground truth in a chemical immunoassay for drug metabolites.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts making decisions on the test set. The "Confirmed Positives" implies a definitive laboratory confirmation method, not a consensus or "X+Y" adjudication by human readers/interpreters.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for imaging diagnostics where human readers interpret medical images. This device is an in vitro diagnostic immunoassay, not an imaging device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies reported are standalone performance characteristics of the assay itself, demonstrating its analytical performance (precision, accuracy, limit of detection). This device is a diagnostic test kit for automated analyzers, meaning its performance is inherently "standalone" from direct human interpretation in the same way an AI algorithm for imaging would be. The "Hitachi 917 Analyzer System" is a "fully automatic, computer-controlled system," indicating the device's operation is automated without human-in-the-loop decision-making impacting the primary result.
7. The Type of Ground Truth Used
The ground truth used for the accuracy study was "Confirmed Positives." In the context of drug screening, this typically refers to confirmatory analytical methods such as Gas Chromatography-Mass Spectrometry (GC/MS) or Liquid Chromatography-Mass Spectrometry (LC/MS), which are considered the gold standard for identifying and quantifying drug metabolites in biological samples. The document does not provide details on which specific confirmatory method was used, but it's clearly not expert consensus, pathology, or outcomes data in the usual sense.
8. The Sample Size for the Training Set
The document does not explicitly state a "training set" sample size or describe a training process. This is common for traditional immunoassay development, which relies on chemical and biological principles rather than machine learning models that require distinct training sets. The development process typically involves optimizing reagent formulations and reaction conditions, followed by validation studies.
9. How the Ground Truth for the Training Set Was Established
As no "training set" is described in the context of machine learning, the question of how ground truth was established for it does not apply in this document. The development of such assays involves established chemical and biological methods for calibrating and validating the assay's ability to detect the target analyte.
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