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The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only.

The Diazyne Fibringen Calibrator Set is intended for use in the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.

The Diazyme Fibringen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.

The performance of this device has not been established in neonate and pediatric patient populations.

Diazyme Fibrinogen Assay System consists of the following items:

• 1. The Diazyme Fibrinogen Assay: containing reagent R1 and reagent R2. Reagent 1 contains buffer, saline, and sodium azide. Reagent 2 containing anti-human fibrinogen Ig fraction tittered to optimal concentrations dependent on sera lot and sodium azide.
• 2. Diazyme Fibrinogen Calibrator Set: 3 levels, serum based, intended for use in the calibration of the Diazyme Fibrinogen Assay. The calibrators are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide
• 3. Diazyme Fibrinogen Control Set: 2 levels, serum based, intended for use as quality controls for the Diazyme Fibrinogen Assay. The controls are in lyophilized form containing purified human fibrinogen antigen, defibrinated human serum and sodium azide.

The Diazyme Fibrinogen Assay is run on Roche Modular P analyzer (K953239/005). The Diazyme Fibrinogen Assay never comes into direct contact with patient's venous blood sample is first collected by a phlebotomist and then submitted for determination of fibrinogen concentration using Diazyme Fibrinogen Assay by trained professionals.

The Control Unit of the Roche Modular P analyzer uses a graphical interface to control all instrument functions. The computer, keyboard, and touchscreen monitor allows users to navigate through the software, enter assay, calibrator, and control information, and make test selections. The Diazyme Fibrinogen Modular P application parameters provided are programmed into the Modular P analyzers. The reagents, calibrators and controls are loaded into the analyzer. The Roche Modular P stores the Diazyme Fibrinogen Assay reagents in a refrigerated compartment. Reagent and sample pipettes automatically aspirate and dispense specified amounts of reagent or calibrators, controls, and sample into reaction cells. The change in absorbance is measured at specified wavelengths.

After a 4-point calibration, spline-fitting is used to smoothly fit polynomial functions through mean values of the response for calibrators of known concentrations. The Roche Modular P calculates the fibrinogen concentration of a patient sample by interpolation of the obtained signal to a stored 4-point calibration curve.

This document describes the Diazyme Fibrinogen Assay and compares its performance characteristics to a predicate device, the Kamiya K-Assay Fibrinogen (K993482), to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a separate, pre-defined set of values that the device met. Instead, it presents performance characteristics and then concludes "Performance data and risk analysis indicates that differences should not affect the safety and effectiveness of the Diazyme Fibrinogen Assay and offers users an in vitro diagnostic device system to measure fibrinogen in human plasma," implicitly suggesting these performance levels are acceptable for substantial equivalence.

Here's a comparison of the Diazyme Fibrinogen Assay's performance against the predicate:

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

• Precision (Sample Repeatability): 6 citrated plasma samples. Tested over 10 days, 2 runs/day, 2 replicates/run = 240 measurements per sample type.
• Precision (Calibrator Repeatability): 3 levels of calibrators. Tested over 10 days, 2 runs/day, 2 replicates/run = 360 measurements per calibrator level.
• Precision (Control Repeatability): 2 levels of controls. Tested over 20 days, 2 runs/day, 2 replicates/run = 160 measurements per control level.
• Reproducibility (Multi-site precision): 6 citrated plasma samples, 3 calibrator levels, 2 control levels. Plasma: 60 measurements per sample (implies 3 sites, but not explicitly stated how many measurements per site). Calibrator/Control: 120 measurements per level.
• Linearity: An eleven-level linearity set prepared by mixing a pooled fibrinogen spiked plasma sample and saline at different proportions.
• Method Comparison: A total of 176 human plasma samples.
• Interference: Not specified as a specific "test set" size, but various interferents were tested at specified concentrations.

Data Provenance:
The document does not explicitly state the country of origin of the samples. For precision, linearity, and interference, it implies in-house testing by Diazyme Laboratories. For method comparison, it states "Human plasma samples" from "3 clinical sites," but the location of these sites and whether the data is retrospective or prospective is not specified.

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

This information is not provided in the document. For in vitro diagnostic devices like this, the "ground truth" for method comparison is typically established by results from the predicate device itself, or in some cases, a well-established reference method. There is no mention of experts establishing a ground truth for individual samples.

4. Adjudication Method for the Test Set

This information is not applicable/provided. For analytical performance studies of quantitative IVD assays, an adjudication method (like 2+1 expert consensus) is typically not used in the same way it would be for qualitative image-based diagnostic systems. The reference method (predicate device) provides the comparative "truth."

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 relevant for diagnostic imaging interpretation where human readers are involved. The Diazyme Fibrinogen Assay is an in vitro diagnostic assay run on an automated analyzer (Roche Modular P), not a system designed for human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance studies described (Precision, Linearity, Method Comparison, Interference) are all standalone performance evaluations of the Diazyme Fibrinogen Assay device itself, without human-in-the-loop performance measurement. The device runs on an automated analyzer (Roche Modular P), and its performance is assessed against established analytical performance metrics and comparison to a predicate device.

7. The Type of Ground Truth Used

For the method comparison study, the predicate device's results (Kamiya K-Assay Fibrinogen) served as the comparative "ground truth" or reference method. For linearity, it was prepared standards. For precision, the "truth" is the statistical mean of repeated measurements.

8. The Sample Size for the Training Set

This information is not applicable/provided. The Diazyme Fibrinogen Assay is an immunoturbidimetric assay based on chemical reactions and optical measurements, not a machine learning or AI-based device that would typically involve a "training set" in the computational sense. The "training" of the assay involves establishing calibration curves using known calibrator concentrations.

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

This information is not applicable/provided. As above, the device is not an AI/ML system requiring a training set with "ground truth" labels. Calibration curves are established using the "Diazyme Fibrinogen Calibrator Set," which contains purified human fibrinogen antigen at known concentrations. These known concentrations serve as the basis for the instrument to interpret sample results.

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The CKMB UDR assay is an in vitro diagnostic test used for the kinetic quantitative determination on Unicel DxC 600 System of the CK-MB isoenzyme activity of creatine kinase in serum and Liheparin plasma by inhibition method. The assay is intended for professional use only. Creatine Kinase (CK) catalyses the reversible phosphorylation of creatine by ATP. CK is a dimer composed of two subunits which form three active isoenzymes: BB (CK-1), MB (CK-2), MM (CK-3). CK-BB isoenzyme only rarely appears in serum.

Elevated CK values are due to muscular damages and associated pathologies. CK determination, usually performed with CK2 (also called CK-MB), is used for the diagnosis and follow-up of AMI (acute myocardial infarction) and some muscular diseases.

Anti CK-M mouse monoclonal antibodies in the reagent 1 inhibit the CK-M subunit in the sample without affecting the CK-B subunits. The CK-B activity is determined by the CK-NAC method and corresponds to half the CK-MB activity.

The provided text describes the performance characteristics of the CKMB UDR Assay, focusing on its substantial equivalence to a predicate device. Here's a breakdown of the acceptance criteria and study details:

1. A table of acceptance criteria and the reported device performance

Study Proving Acceptance Criteria (Type of Study):

The study described is a comparative performance study to demonstrate substantial equivalence to a predicate device (Roche CK-MB assay K003158). This is primarily an analytical validation study.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: 306 human sera samples (for method comparison).
• Data Provenance: The text does not specify the country of origin. It implicitly describes a prospective study in the sense that samples were tested with both the new device and the predicate for comparison. However, the exact collection method (e.g., whether samples were collected specifically for this study or were existing banked samples) is not explicitly stated. It is referred to as "human sera samples," suggesting clinical samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of analytical device validation. The "ground truth" for an assay like CKMB is established by the reference method (in this case, the predicate device) and the intrinsic chemical/biological properties being measured, not by expert consensus on interpretations.

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

Not applicable. This is not a study involving human interpretation or adjudication of results. The comparison is quantitative between two analytical instruments.

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

Not applicable. This is an in vitro diagnostic assay, not an imaging device or AI-assisted diagnostic tool that involves human readers.

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

Yes, the studies described are standalone (algorithm/assay only) performance assessments. The device measures CK-MB activity directly, and its performance is evaluated based on its analytical characteristics (correlation, precision, range) against a predicate device, without human intervention in the result determination.

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

The "ground truth" in this context is the results obtained from the legally marketed predicate device (Roche CK-MB assay K003158). The study aimed to demonstrate that the new device's measurements are substantially equivalent to those of the predicate device. For the imprecision and AMR studies, the ground truth is implicitly the inherent biological measurement of the samples at various concentrations using the new device.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI-driven device that requires a training set in that sense. It is a chemical assay.

9. How the ground truth for the training set was established

Not applicable, as there is no training set for this type of device.

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The Tina-quant Albumin Gen. 2 assay is an immunoturbidimetric assay intended for the quantitative determination of albumin in serum, plasma, urine, and CSF on Roche/Hitachi cobas c systems. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

The Tina-quant Albumin Gen. 2 assay employs an immunoturbidimetric test in which anti-albumin antibodies react with the antigen in the sample to form antigen/antibody complexes which, following agglutination are determined turbidimetrically.

The provided document describes the Tina-quant Albumin Gen. 2 assay, an immunoturbidimetric test for quantitative determination of albumin in human urine, serum, plasma and CSF on Roche/Hitachi cobas c systems.

Here's an analysis of the acceptance criteria and the studies performed, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents separate substantial equivalence comparisons for the urine, serum/plasma, and CSF applications of the Tina-quant Albumin Gen. 2 assay against predicate devices. The "acceptance criteria" are implied by the measured performance parameters, as they are being compared to the predicate device and found to be substantially equivalent.

Table 1: Urine Application Performance Comparison

Table 2: Serum/Plasma Application Performance Comparison

Table 3: CSF Application Performance Comparison

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

• Urine Application Method Comparison:

  • Sample Size: n = 125
  • Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). The comparison is between the Tina-quant Albumin Gen. 2 assay on the c501 analyzer and the Hitachi Microalbumin assay on the Hitachi 917 analyzer (K953239). The sample concentrations were between 12.3 and 386 mg/L.

• Serum/Plasma Application Method Comparison:

  • Sample Size: n = 77
  • Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 5.70 and 100 g/L.

• CSF Application Method Comparison:

  • Sample Size: n = 85
  • Provenance: Not explicitly stated. The comparison is between the Tina-quant Albumin Gen. 2 assay on the cobas c501 analyzer and a nephelometric Albumin test. The sample concentrations were between 115 and 2640 mg/L.

• Precision, Sensitivity, Specificity, Interferences:

  • The sample sizes for these internal studies are not explicitly mentioned in the provided text for each specific test, but they are implied to be sufficient for analytical validation. Provenance is also not explicitly stated.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

• The document describes an in-vitro diagnostic device for quantitative determination of albumin. The "ground truth" here is the actual albumin concentration in the samples, established by reference methods or predicate devices, rather than expert interpretation of images or other subjective data.
• Therefore, the concept of "experts" to establish a subjective ground truth (like radiologists for imaging) is not directly applicable to this type of analytical device. The references are to other cleared devices (predicate devices) or established analytical methods.

4. Adjudication Method for the Test Set

• As the device provides a quantitative measurement, and the "ground truth" is established by a reference method or predicate device performance, there is no mention of an "adjudication method" in the sense of reconciling differences between multiple human interpreters. This concept is typically relevant for subjective assessments (e.g., medical image interpretation).

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

• No MRMC comparative effectiveness study was done. This type of study is relevant for devices that assist human readers (e.g., AI in radiology). The Tina-quant Albumin Gen. 2 assay is a standalone diagnostic test performed by an automated analyzer, not an assistive technology for human interpreters.

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

• Yes, the performance data presented is for the standalone device (Tina-quant Albumin Gen. 2 assay on the Roche/Hitachi cobas c systems) without human intervention for the measurement itself. The results are quantitative values generated by the automated system. The accuracy is assessed by correlation with predicate devices/methods.

7. The Type of Ground Truth Used

• The ground truth for the performance studies (specifically method comparisons) was established by comparison to existing, legally marketed predicate devices or established nephelometric albumin tests. This implies that the predicate devices/methods themselves served as the reference standard for the "true" albumin values in the samples.
  • For urine, the predicate was the Hitachi Microalbumin urine assay (K932950).
  • For serum/plasma and CSF, the predicate was the Behring Nephelometric method (K972929).

8. The Sample Size for the Training Set

• The document describes a 510(k) submission for substantial equivalence. This is for a conventional in-vitro diagnostic (IVD) assay, not a machine learning or AI-based device that typically involves "training sets." Therefore, the concept of a "training set" in the context of machine learning is not applicable here. The assay relies on established immunoturbidimetric principles, and performance is validated through analytical studies on test samples.

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

• As explained in point 8, the concept of a "training set" is not applicable to this device submission.

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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 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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