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Abuscreen ONLINE for Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on the Hitachi 917 analyzer at a cutoff of 200 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 barbiturate use or abuse.

Abuscreen ONLINE Barbiturates is an in vitro diagnostic test for the qualitative and semiquantitative detection of barbiturates in human urine on automated clinical chemistry analyzers at a cutoff of 200 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 barbiturate use or abuse. The proposed Abuscreen ONLINE Barbiturates 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 Barbiturates test kit. The labeling and packaging have been modified for use on the Hitachi 917 Analyzer as well as a modification to the buffer formulation and the 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 a breakdown of the acceptance criteria and the study details for the Abuscreen ONLINE® Barbiturates device, based on the provided text:

Acceptance Criteria and Device Performance

Study Information:

1. Sample size used for the test set and the data provenance:

   • Accuracy Test Set: N=50 for the proposed device (confirmed positively for barbiturates).
   • Accuracy Test Set (Predicate): N=74 for the predicate device (confirmed positively for barbiturates).
   • Precision Test Set: The number of runs/replicates for the precision studies (within-run and day-to-day for both qualitative and quantitative) is not explicitly stated in the provided text.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the text. The term "Confirmed Pos." is used for accuracy, implying a reference method was used to establish ground truth, but who performed it or their qualifications are not mentioned.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided in the text.

4. 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:

   • No. This device is an in vitro diagnostic (IVD) immunoassay for detecting barbiturates in urine. It's a laboratory test, not an AI-assisted diagnostic imaging tool that would involve human readers. Therefore, an MRMC study or AI assistance is not applicable.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This refers to the performance of the device itself (the immunoassay on the Hitachi 917 analyzer). The data presented in "Table 3" (Proposed column) is the standalone performance of the device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For accuracy, the ground truth was established by "Confirmed Pos." This strongly suggests a confirmatory analytical method (e.g., GC/MS) for the presence of barbiturates, rather than expert clinical consensus or pathology, as is common for drug screening tests.

7. The sample size for the training set:

   • This information is not provided as this is an immunoassay kit (chemical reagents and method), not a machine learning algorithm that requires a "training set" in the traditional sense. The development of such assays involves formulation, calibration, and optimization, not a data-driven training process.

8. How the ground truth for the training set was established:

   • Not applicable, as there isn't a "training set" in the context of an immunoassay kit for machine learning. The "ground truth" for calibrators would be established through precise analytical methods to create known concentrations.

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Abuscreen ONLINE Benzodiazepines is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on the Hitachi 917 analyzer at cutoff concentrations of 100 ng/mL, 200 ng/mL, and 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 benzodiazepine use or abuse.

The proposed Abuscreen ONLINE Benzodiazepines 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 Benzodiazepines 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 a breakdown of the acceptance criteria and study information for the Abuscreen ONLINE® Benzodiazepines device, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document details various performance characteristics used to demonstrate substantial equivalence to the predicate device. The acceptance criteria are implicitly set by matching or surpassing the predicate's performance and demonstrating acceptable levels of precision and accuracy at different cut-off concentrations.

Table of Acceptance Criteria and Reported Device Performance

95% positive at 250 ng/mL |
| Quantitative Precision (200 ng/mL Cutoff) - Within Run CV% | Not applicable for predicate | 100 ng/mL: 0.7%, 150 ng/mL: 1.3%, 200 ng/mL: 1.6%, 250 ng/mL: 1.8%, 300 ng/mL: 1.8% |
| Quantitative Precision (200 ng/mL Cutoff) - Day-to-Day CV% | Not applicable for predicate | 100 ng/mL: 2.7%, 150 ng/mL: 1.5%, 200 ng/mL: 1.5%, 250 ng/mL: 2.6%, 300 ng/mL: 3.1% |
| Qualitative Precision (300 ng/mL Cutoff) | Not explicitly stated for predicate in summary | >95% negative at 225 ng/mL
95% positive at 375 ng/mL |
| Quantitative Precision (300 ng/mL Cutoff) - Within Run CV% | Not applicable for predicate | 150 ng/mL: 1.7%, 225 ng/mL: 2.6%, 300 ng/mL: 1.9%, 375 ng/mL: 1.3%, 450 ng/mL: 1.2% |
| Quantitative Precision (300 ng/mL Cutoff) - Day-to-Day CV% | Not applicable for predicate | 150 ng/mL: 2.2%, 225 ng/mL: 2.7%, 300 ng/mL: 3.1%, 375 ng/mL: 2.9%, 450 ng/mL: 2.4% |
| Accuracy (100 ng/mL Cutoff) | N= 48 Confirmed Pos.
47 Pos. 1 Neg. | N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
N= 10 diluted within 25% above cutoff: 10 Pos. 0 Neg.
N= 10 diluted within 25% below cutoff: 0 Pos. 10 Neg. |
| Accuracy (200 ng/mL Cutoff) | Not applicable for predicate | N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
N= 10 diluted within 25% above cutoff: 10 Pos. 0 Neg.
N= 10 diluted within 25% below cutoff: 0 Pos. 10 Neg. |
| Accuracy (300 ng/mL Cutoff) | Not applicable for predicate | N= 50 Confirmed Pos.: 50 Pos. 0 Neg.
N= 10 diluted within 25% above cutoff: 10 Pos. 0 Neg.
N= 10 diluted within 25% below cutoff: 0 Pos. 10 Neg. |
| Limit of Detection | 61 ng/mL (clinical sensitivity) | 100 Cutoff - 13 ng/mL
200 Cutoff - 16 ng/mL
300 Cutoff - 28 ng/mL |

Study Details

1. Sample size used for the test set and the data provenance:

   • Precision Studies: The specific sample sizes for "Within Run" and "Day-to-Day" precision studies are provided in terms of replicates for different concentrations (e.g., 50 ng/mL, 75 ng/mL, etc.), but the total number of individual samples is not explicitly given. Each CV% calculation likely represents a set of replicates.
   • Accuracy Studies:
     • 100 ng/mL Cutoff: N=50 Confirmed Positive samples, N=10 samples diluted within 25% above cutoff, N=10 samples diluted within 25% below cutoff.
     • 200 ng/mL Cutoff: N=50 Confirmed Positive samples, N=10 samples diluted within 25% above cutoff, N=10 samples diluted within 25% below cutoff.
     • 300 ng/mL Cutoff: N=50 Confirmed Positive samples, N=10 samples diluted within 25% above cutoff, N=10 samples diluted within 25% below cutoff.
   • Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It describes the data as "clinical and nonclinical studies performed," which typically implies prospective data collection for performance evaluation of a new device.

2. 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 about the number or qualifications of experts used to establish the ground truth. For drug screening tests, "confirmed positive" usually refers to confirmation by a highly sensitive and specific method like GC/MS (Gas Chromatography-Mass Spectrometry), which serves as the analytical ground truth.

3. Adjudication method for the test set:
   The document does not describe an adjudication method for the test set. For in vitro diagnostic tests, especially for drug screening, the "ground truth" is typically the result from a definitive confirmatory method (e.g., GC/MS), not subjective interpretation by human readers requiring adjudication.

4. 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:
   No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an in vitro diagnostic test for the qualitative and semiquantitative detection of benzodiazepines in human urine on automated clinical chemistry analyzers. It is an automated assay and does not involve human readers interpreting results in the way an imaging diagnostic device might. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   Yes, this entire submission is a standalone performance evaluation of the automated assay (the "algorithm only") on the Hitachi 917 Analyzer. The device itself is an in vitro diagnostic test, which by nature operates as a standalone system to detect analytes in a sample.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the accuracy studies, the ground truth is referred to as "Confirmed Pos." (Confirmed Positive), which in the context of drug screening tests typically means confirmation by a highly specific and sensitive analytical method such as Gas Chromatography-Mass Spectrometry (GC/MS). This is an analytical ground truth.

7. The sample size for the training set:
   The document does not explicitly state a "training set" sample size. For in vitro diagnostic devices like this, the development process involves reagent formulation and optimization that leverages proprietary internal data and methods, but it's not typically described in terms of a "training set" in the way machine learning algorithms are. The provided data focuses on the validation of the finalized assay.

8. How the ground truth for the training set was established:
   As no explicit "training set" is mentioned in the machine learning sense, the method for establishing its ground truth is not described. The analytical methods used to establish the reference values for calibrators and controls used during the development and validation of the assay would serve a similar purpose to ground truth in a broader sense.

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Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on the Hitachi 917 analyzer at a cutoff concentration of 25 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 phencyclidine use or abuse.

Abuscreen ONLINE for Phencyclidine is an in vitro diagnostic test for the qualitative and semiquantitative detection of phencyclidine and its metabolites in human urine on automated clinical chemistry analyzers at a cutoff concentration of 25 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 phencyclidine use or abuse.

The proposed Abuscreen ONLINE Phencyclidine 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 Phencyclidine 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 testprocessing. 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.

1. Table of Acceptance Criteria and Reported Device Performance

95% positive at 31.25 ng/mL | >95% negative at 18.75 ng/mL
95% positive at 31.25 ng/mL | >95% negative at 20 ng/mL
95% positive at 30 ng/mL |
| Precision (Within Run) - OD (CV%) | Not explicitly stated as acceptance criteria, but reported values are compared to predicate. | 12.5 ng/mL: 2.9%
18.75 ng/mL: 3.3%
25.0 ng/mL: 1.8%
31.25 ng/mL: 2.0%
37.5 ng/mL: 1.2% | Not provided in terms of individual CVs for predicate, only qualitative stated. |
| Precision (Day-to-Day) - OD (CV%) | Not explicitly stated as acceptance criteria, but reported values are compared to predicate. | 12.5 ng/mL: 3.3%
18.75 ng/mL: 4.8%
25.0 ng/mL: 3.5%
31.25 ng/mL: 3.3%
37.5 ng/mL: 3.1% | Not provided in terms of individual CVs for predicate, only qualitative stated. |
| Precision (Within Run) - Quantitative (CV%) | Not explicitly stated as acceptance criteria, but reported values are compared to predicate. | 12.5 ng/mL: 6.2%
18.75 ng/mL: 4.3%
25.0 ng/mL: 2.0%
31.25 ng/mL: 2.1%
37.5 ng/mL: 1.9% | 12.5 ng/mL: 7%
18.75 ng/mL: 6%
25.0 ng/mL: 3%
31.25 ng/mL: 3% |
| Precision (Day-to-Day) - Quantitative (CV%) | Not explicitly stated as acceptance criteria, but reported values are compared to predicate. | 12.5 ng/mL: 8.6%
18.75 ng/mL: 6.6%
25.0 ng/mL: 5.0%
31.25 ng/mL: 4.0%
37.5 ng/mL: 3.4% | 12.5 ng/mL: 10%
18.75 ng/mL: 5%
25.0 ng/mL: 3%
31.25 ng/mL: 3% |
| Accuracy (25 ng/mL Cutoff) | Not explicitly stated as a numerical acceptance criterion, but demonstrated by agreement with confirmed samples. | N=50 Confirmed Pos.: 50 Pos., 0 Neg.
N=14 (25% above cutoff): 14 Pos., 0 Neg.
N=14 (25% below cutoff): 0 Pos., 14 Neg. | N=75 Confirmed Pos.: 75 Pos., 0 Neg. |
| Limit of Detection | Comparability to predicate device. | 0.6 ng/mL | 6 ng/mL (clinical sensitivity) |

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size:
  • Precision (Qualitative & Quantitative): The document reports "Mean (OD)" and "Mean (ng/mL)" values for various concentrations (12.5, 18.75, 25.0, 31.25, 37.5 ng/mL) under "Within Run" and "Day-to-Day" conditions. While the exact number of replicates per run/day isn't explicitly stated, the CV% values indicate multiple measurements were taken for each concentration.
  • Accuracy:
    • N = 50 confirmed positive samples.
    • N = 14 samples diluted within 25% above cutoff concentration.
    • N = 14 samples diluted within 25% below cutoff concentration.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It presents the data as performance characteristics obtained from clinical and nonclinical studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The "Confirmed Pos." in the Accuracy section implies a confirmatory method was used, but the details of who performed this confirmation and their expertise are not given.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. This device is an in vitro diagnostic test for chemical analysis, not an imaging device requiring human reader interpretation in the same way.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the study describes the standalone performance of the Abuscreen ONLINE Phencyclidine for Hitachi 917 device. The precision and accuracy data reflect the performance of the automated system operating independently. The "semisuantitative test results may be obtained that permit laboratories to assess assay performance as part of a quality control program," indicating the automated nature of the results.

7. Type of Ground Truth Used

The ground truth for the "Accuracy" section was established by "Confirmed Pos." meaning it was likely confirmed by an independent, more definitive analytical method, although the specific method (e.g., GC/MS) is not explicitly named. It is based on analytical confirmation rather than pathology or outcome data.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. This type of device (enzyme immunoassay) is typically characterized and validated rather than trained in the machine learning sense. The data presented are for evaluating the performance of the developed assay.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for this type of device, the method for establishing ground truth for a training set is not applicable or provided. The "ground truth" in this context refers to accurately known concentrations of phencyclidine in samples used for validation and verification, which would be established through highly accurate analytical methods.

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Abuscreen ONLINE BENZ 200 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Abuscreen ONLINE BENZ 200 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. The matrix is urine and the levels of Benzodiazepines (ng/mL) are 0, 100, 200, 400.

The provided text states that "No clinical or nonclinical tests were necessary to establish substantial equivalence." Therefore, there is no information in the document to fill in the requested table and answer the study-related questions.

Without a study being conducted or detailed in the provided text, it is not possible to describe acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document is a 510(k) summary for Abuscreen ONLINE® BENZ 200 Calibrators, stating its substantial equivalence to a predicate device based on similar technological characteristics rather than new performance data.

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Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens.

Abuscreen ONLINE BENZ 300 Calibrators are designed for the calibration of the Roche assays for Benzodiazepines. This clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the measurement of substances in human specimens.

The provided text describes a 510(k) submission for "Abuscreen ONLINE® BENZ 300 Calibrators". However, the document explicitly states: "No clinical or nonclinical tests were necessary to establish substantial equivalence."

Therefore, based on the provided text, there is no study described that proves the device meets specific acceptance criteria. The submission establishes equivalence to a predicate device ("Abuscreen ONLINE Calibration Pack," K951595) based on technological characteristics rather than performance data from a new study.

Here's a breakdown of why I cannot fulfill your request for performance data and study details:

• Acceptance Criteria and Reported Device Performance: No acceptance criteria or reported device performance for the new device are mentioned in the text. The only performance-related information provided is a comparison of benzodiazepine levels (ng/mL) for calibration, which are simply the concentrations offered by the calibrators, not performance metrics.
• Sample Size for Test Set and Data Provenance: Not applicable as no new test set or study was conducted.
• Number of Experts and Qualifications: Not applicable.
• Adjudication Method: Not applicable.
• MRMC Comparative Effectiveness Study: Not applicable.
• Standalone Performance: Not applicable.
• Type of Ground Truth: Not applicable.
• Sample Size for Training Set: Not applicable.
• How Ground Truth for Training Set was Established: Not applicable.

The submission focuses solely on establishing substantial equivalence to a previously cleared device by comparing characteristics like matrix, intended use, and the levels of benzodiazepines in the calibrators.

Table of Acceptance Criteria and Reported Device Performance:

Explanation of Study (or lack thereof):

The document explicitly states in Section VI: "Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence: No clinical or nonclinical tests were necessary to establish substantial equivalence."

This means that a new study as you describe (with test sets, ground truth, expert review, etc.) was not performed for this 510(k) submission. Substantial equivalence was determined based on a comparison of the new device's characteristics (matrix, intended use, and calibration levels) with those of an already legally marketed predicate device (Abuscreen ONLINE Calibration Pack, K951595). The changes in the benzodiazepine levels (0, 150, 300, 600 ng/mL for the new device versus 0, 50, 100, 200 ng/mL for the predicate) are presented as a characteristic difference, not as a result of performance testing in this specific 510(k).

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Abuscreen ONLINE for Propoxyphene is an in vitro diagnostic test for the qualitative and semiquantitative detection of propoxyphene and its metabolites 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 propoxyphene use or abuse.

The proposed Abuscreen ONLINE Propoxyphene 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 Propoxyphene 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 acceptance criteria and supporting study for the Abuscreen ONLINE® Propoxyphene device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Abuscreen ONLINE® Propoxyphene device can be inferred by comparing its performance to that of its legally marketed predicate device (K945195). The study demonstrates that the new device performs equivalently to the predicate.

95% positive at 360 ng/mL | >95% negative at 225 ng/mL
95% positive at 375 ng/mL |
| Precision Quantitative (Within Run) | Representative values from K945195:
200 ng/mL: 208 ng/mL (3% CV)
250 ng/mL: 262 ng/mL (2% CV)
300 ng/mL: 292 ng/mL (1% CV)
340 ng/mL: 329 ng/mL (1% CV) | 150 ng/mL: 153 ng/mL (2.0% CV)
225 ng/mL: 239 ng/mL (1.3% CV)
300 ng/mL: 306 ng/mL (1.6% CV)
375 ng/mL: 440 ng/mL (1.0% CV)
450 ng/mL: 473 ng/mL (0.6% CV) |
| Precision Quantitative (Day-to-Day) | Representative values from K945195:
200 ng/mL: 208 ng/mL (3% CV)
250 ng/mL: 262 ng/mL (2% CV)
300 ng/mL: 293 ng/mL (1% CV)
340 ng/mL: 331 ng/mL (1% CV) | 150 ng/mL: 147 ng/mL (5.2% CV)
225 ng/mL: 236 ng/mL (3.1% CV)
300 ng/mL: 302 ng/mL (2.4% CV)
375 ng/mL: 435 ng/mL (2.4% CV)
450 ng/mL: 467 ng/mL (1.2% CV) |
| Accuracy (300 ng/mL Cutoff) | N= 63 Confirmed Pos.
63 Pos.
0 Neg. | N= 50 Confirmed Pos.
50 Pos.
0 Neg. |
| Limit of Detection | 30 ng/mL | 0 ng/mL |

Study Proving Device Meets Acceptance Criteria:

The study described is a non-clinical evaluation comparing the "Abuscreen ONLINE Propoxyphene for Hitachi 917" (the proposed device) against the "Abuscreen ONLINE Propoxyphene (1000 Test Kit)" (the predicate device, K945195). The study aims to demonstrate substantial equivalence based on performance characteristics.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Qualitative Precision: The document states that for the qualitative precision at 300 ng/mL cutoff, the proposed device showed:
  • ">95% negative at 225 ng/mL" and ">95% positive at 375 ng/mL". This implies multiple samples were tested at these concentrations to achieve statistical significance for the percentages reported, but the exact number of individual samples is not explicitly given.
• Sample Size for Quantitative Precision: The within-run and day-to-day precision data are presented as Mean (OD) and CV% for Optical Density (OD) values and Mean (ng/mL) and CV% for concentration values at various propoxyphene levels (150, 225, 300, 375, 450 ng/mL). The number of replicates or runs to calculate these means and CVs is not explicitly stated.
• Sample Size for Accuracy:
  • Proposed device: N= 50 Confirmed Pos. (meaning 50 samples with confirmed positive results were tested).
• Data Provenance: Not explicitly stated. Given the context of a 510(k) submission from Roche Diagnostic Systems, Inc. in New Jersey, USA, it's highly probable the data was generated in the United States, likely in a laboratory setting or using banked samples. The study is retrospective in the sense that it evaluates the performance of the developed device against established predicate performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Not Applicable: This type of device (in vitro diagnostic for drug detection) does not typically involve expert review of images or clinical assessments to establish ground truth in the same way as, for example, a radiology AI device. The ground truth for such assays is established through analytical methods, often using reference standards or confirmed positive/negative samples.

4. Adjudication Method

• Not Applicable: As mentioned above, this device does not involve human interpretation or subjective assessment that would require an adjudication method. The results are quantitative or qualitative measurements from an automated clinical chemistry analyzer.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: This is not relevant for this type of in vitro diagnostic device. MRMC studies are typically used for imaging AI devices that assist human readers in tasks like lesion detection or diagnosis. This device provides a direct analytical measurement.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes: The entire study described focuses on the standalone performance of the "Abuscreen ONLINE Propoxyphene for Hitachi 917" test kit (the proposed device) as an automated assay. It measures its analytical performance characteristics directly, without a human in the diagnostic loop to interpret the results from the device itself. The device directly outputs qualitative or semi-quantitative measurements.

7. Type of Ground Truth Used

• The ground truth for the test set is established by the confirmed concentration of propoxyphene and its metabolites in urine samples. For accuracy, it relies on "Confirmed Pos." samples, implying independent verification of the presence of the drug at or above the cutoff. For precision, it uses samples spiked or prepared to precise known concentrations.

8. Sample Size for the Training Set

• Not explicitly stated: This document describes a 510(k) submission for a new formulation of an existing immunoassay to be run on a specific analyzer. Immunoassays are based on biochemical interactions, not machine learning algorithms that require explicit "training sets" in the computational sense. The "training" for such a device involves optimizing reagent concentrations, reaction conditions, and calibration curves during its development. The text implies the device was "adapted from the currently marketed Abuscreen ONLINE Propoxyphene test kit," suggesting that the underlying assay principles and initial development would have been established previously.

9. How the Ground Truth for the Training Set Was Established

• Not explicitly stated/Not Applicable in the AI/ML sense: As above, this is an immunoassay, not an AI/ML model. The "ground truth" during the development and optimization of such an assay (analogous to a training set) would involve extensive analytical experiments using:
  • Reference standards of propoxyphene and its metabolites at known concentrations.
  • Characterized positive and negative urine samples.
  • Samples with known interfering substances.
  • The goal of this "training" phase is to ensure the assay reagents and conditions provide accurate and precise measurements across the intended dynamic range and specificity.

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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.

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Abuscreen ONLINE for Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.

Abuscreen ONLINE Amphetamines is an in vitro diagnostic test for the qualitative and semiquantitative detection of amphetamine and methamphetamine and their metabolites in human urine on automated clinical chemistry analyzers at a cutoff of 1000 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 amphetamine use or abuse.

The proposed Abuscreen ONLINE Amphetamines 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 Amphetamines test kit. The reagent compositions are the same as the previously cleared Abuscreen ONLINE Amphetamines 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 a breakdown of the acceptance criteria and study information for the Abuscreen ONLINE® Amphetamines device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document explicitly states, "The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to the legally marketed predicate device." The proposed device generally demonstrates equal or superior performance compared to the predicate.

Study Details

1. Sample size used for the test set and the data provenance:

   • Accuracy Test Set:
     • Number of samples: N = 50 confirmed positive samples.
     • Data provenance: Not explicitly stated, but assumed to be retrospective or prospective clinical samples given the context of "confirmed positive." No country of origin is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The term "Confirmed Pos." suggests a definitive method for determining the true positive status, likely an orthogonal method like GC/MS (Gas Chromatography-Mass Spectrometry), which is common for drug screening confirmation, rather than expert consensus on images or clinical interpretation.

3. Adjudication method for the test set:

   • Not applicable/Not described. The ground truth (confirmed positive) would be established by an analytical method rather than a human adjudication process in this diagnostic context.

4. 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:

   • No MRMC study was done. This device is an in vitro diagnostic for chemical analysis, not an imaging or interpretive device that would typically involve human readers or AI assistance in that manner.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance characteristics presented (Precision, Accuracy, LOD) are those of the device itself (reagent kit on the Hitachi 917 Analyzer), operating automatically without human interpretive input for the result generation. The device is intended for "qualitative and semiquantitative detection," which are objective measurements.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • For Accuracy: "Confirmed Pos." (Confirmed Positive). This almost invariably refers to confirmation by a highly sensitive and specific analytical method, such as Gas Chromatography-Mass Spectrometry (GC/MS), which is considered the gold standard for drug confirmation testing.
   • For Precision: Controlled samples with known concentrations (e.g., 500 ng/mL, 750 ng/mL, etc.) were used, making the true concentration the ground truth.

7. The sample size for the training set:

   • Not applicable/Not explicitly stated. This device is an immunoassay, not a machine learning or AI-driven system that would typically undergo a separate "training" phase with a distinct dataset in the modern sense. Its performance is based on the chemical reactivity of its components and its integration with the analyzer. Development and optimization would have occurred, but not in the "training set" paradigm of current AI.

8. How the ground truth for the training set was established:

   • Not applicable, as there's no explicit "training set" as understood in current AI/ML development. The "ground truth" for method development would involve preparing samples with known concentrations of drug metabolites and using reference methods (like GC/MS) to characterize unknown samples used during the development and validation of the assay's chemical and enzymatic reactions.

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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.

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Abuscreen ONLINE for Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 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 cannabinoid use or abuse.

Abuscreen ONLINE Cannabinoids is an in vitro diagnostic test for the qualitative and semiquantitative detection of cannabinoids and its metabolites in human urine on automated clinical chemistry analyzers at cutoff concentrations of 20 ng/mL, 50 ng/mL, and 100 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 cannabinoid use or abuse.

The proposed Abuscreen ONLINE Cannabinoids 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 Cannabinoids 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 throughout 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.

The Abuscreen ONLINE Cannabinoids device meets its acceptance criteria through various performance characteristics, primarily precision (qualitative and quantitative) and accuracy studies across different cutoff concentrations (20 ng/mL, 50 ng/mL, and 100 ng/mL).

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by performing "Precision Qualitative" where >95% negative at a concentration below the cutoff and >95% positive at a concentration above the cutoff should be observed. Precision is also assessed by coefficients of variation (CV%) for both within-run and day-to-day measurements of optical density (OD) and concentration (ng/mL). Accuracy is assessed by comparing the device's qualitative results with confirmed positive samples.

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