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510(k) Data Aggregation
(51 days)
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 methadone use or abuse.
Abuscreen ONLINE Methadone is an in vitro diagnostic test for the qualitative and semiquantitative detection of methadone in human urine on automated clinical chemistry analyzers at a cutoff concentration 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 methadone use or abuse. The proposed Abuscreen ONLINE Methadone 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 Methadone test kit. The labeling and packaging have been changed for use on the Hitachi 917 Analyzer as well as an addition of a surfactant to the diluent. 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 Abuscreen ONLINE® Methadone device, focusing on its acceptance criteria and the supporting study:
The document is a 510(k) summary for a medical device called "Abuscreen ONLINE® Methadone," an in vitro diagnostic test for detecting methadone in human urine. The submission date is October 20, 1998, and it was reviewed by the FDA, resulting in a substantial equivalence determination on December 11, 1998.
1. Table of Acceptance Criteria and the Reported Device Performance
The acceptance criteria are implied by the performance characteristics presented for the "Proposed: Abuscreen ONLINE Methadone for Hitachi 917" device, which are compared to a "Previously Cleared: (K930928) Abuscreen ONLINE Methadone (1000 Test Kit)" predicate device. The goal of the study is to demonstrate that the new device performs equivalently to the predicate.
| Performance Characteristic | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Proposed) |
|---|---|---|
| Qualitative Precision (300 ng/mL Cutoff): | ||
| Negative at 225 ng/mL | >95% negative at 240 ng/mL | >95% negative at 225 ng/mL |
| Positive at 375 ng/mL | >95% positive at 360 ng/mL | >95% positive at 375 ng/mL |
| Quantitative Precision (300 ng/mL Cutoff): | ||
| Within Run: | ||
| 150 ng/mL Mean (ng/mL) | 152 | 148 |
| 150 ng/mL CV% | 4 | 2.4 |
| 225 ng/mL Mean (ng/mL) | 235 (at 240 ng/mL conc.) | 220 |
| 225 ng/mL CV% | 3 (at 240 ng/mL conc.) | 3.2 |
| 300 ng/mL Mean (ng/mL) | 301 | 299 |
| 300 ng/mL CV% | 1 | 1.5 |
| 375 ng/mL Mean (ng/mL) | 340 (at 340 ng/mL conc.) | 411 |
| 375 ng/mL CV% | 1 (at 340 ng/mL conc.) | 1.0 |
| Day-to-Day: | ||
| 150 ng/mL Mean (ng/mL) | 151 | 151 |
| 150 ng/mL CV% | 4 | 4.2 |
| 225 ng/mL Mean (ng/mL) | 236 (at 240 ng/mL conc.) | 222 |
| 225 ng/mL CV% | 3 (at 240 ng/mL conc.) | 3.7 |
| 300 ng/mL Mean (ng/mL) | 297 | 303 |
| 300 ng/mL CV% | 3 | 2.2 |
| 375 ng/mL Mean (ng/mL) | 340 (at 340 ng/mL conc.) | 407 |
| 375 ng/mL CV% | 1 (at 340 ng/mL conc.) | 2.0 |
| Accuracy (300 ng/mL Cutoff): | ||
| Confirmed Positive results | 73 Positive, 0 Negative (from N=73 Confirmed Pos.) | 50 Positive, 0 Negative (from N=50 Confirmed Pos.) |
| Limit of Detection | < 15 ng/mL | 19 ng/mL |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document refers to the data as "clinical and nonclinical tests," but it does not specify the provenance (e.g., country of origin) or whether the data was retrospective or prospective.
- Accuracy Test Set Sample Size:
- N = 50 confirmed positive samples were used to evaluate accuracy for the proposed device (all 50 were reported as positive, 0 negative).
- For comparison, the predicate device had N = 73 confirmed positive samples (all 73 were reported as positive, 0 negative).
- Precision Test Set Sample Size: The document lists "Within Run" and "Day-to-Day" precision data at different methadone concentrations (150, 225, 300, 375, 450 ng/mL). However, it does not explicitly state the number of replicate measurements or the total sample size for these precision studies. It only provides the mean and Coefficient of Variation (CV%).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts used, their qualifications, or how the ground truth was established for the "Accuracy" test set (where samples were "Confirmed Pos."). It implies a confirmed status, but the method of confirmation is not detailed.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This device is an in vitro diagnostic assay, not an imaging or interpretive AI system that typically involves human readers. The study compares the performance of the automated assay to a predicate automated assay.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The "Abuscreen ONLINE Methadone" device is an automated clinical chemistry analyzer test that detects methadone in urine. The performance characteristics described (precision, accuracy, limit of detection) are intrinsic to the device's analytical function without direct human interpretation in the results generation. Human involvement is limited to operating the analyzer and interpreting the final quantitative/qualitative results provided by the machine.
7. The Type of Ground Truth Used
The ground truth used for the accuracy study is referred to as "Confirmed Pos." for the samples. However, the method of confirmation (e.g., reference method like GC/MS, pathology, or clinical outcome data) is not specified in the provided text. For diagnostic tests, "confirmed positive" usually refers to confirmation by a more definitive or gold-standard method.
8. The Sample Size for the Training Set
The document does not provide information about a training set. This submission is for an in vitro diagnostic immunoassay, not a machine learning or AI-based device that typically undergoes a distinct training phase. These types of assays are developed and validated through laboratory testing to establish their analytical characteristics.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned (see point 8), there is no information on how its ground truth was established.
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