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The BD FACS™ Sample Prep Assistant III is intended to prepare human whole blood for flow cytometric analysis on BD FACSCanto™ II and BD FACSCalibur™ flow cytometry systems.

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCanto™ II flow cytometry systems:

• BD Multitest 6-Color TBNK Reagent with or without BD Trucount Tubes .
• BD Multitest IMK Kit with or without BD Trucount Tubes .
• BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
• BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes

Pipetting blood, reagents, and lysing solution using the following previously cleared assays for flow cytometric analysis on BD FACSCalibur™ flow cytometry systems:

• BD Multitest IMK Kit with or without BD Trucount Tubes .
• BD Multitest CD3 FITC/CD16+CD56 PE/CD45 PerCP/CD19 APC with or . without BD Trucount Tubes
• BD Multitest CD3 FITC/CD8 PE/CD45 PerCP/CD4 APC with or without BD . Trucount Tubes
• BD Tritest CD3/CD16+56/CD45 with or without BD Trucount Tubes .
• BD Tritest CD3/CD19/CD45 with or without BD Trucount Tubes .
• BD Tritest CD3/CD4/CD45 with or without BD Trucount Tubes .
• BD Tritest CD3/CD8/CD45 with or without Trucount Tubes .
• BD Tritest CD4/CD8/CD3 with BD Trucount Tubes .

For in vitro diagnostic use.

The BD FACS™ Sample Prep Assistant III (SPA III) is a microprocessorcontrolled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCalibur flow cytometer, the SPA III combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis.

The SPA III pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning procedures. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

Here's a breakdown of the acceptance criteria and study information for the BD FACS™ Sample Prep Assistant III, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

Important Note: The document does not explicitly state numerical acceptance criteria for accuracy, precision, or carryover. It refers to established guidelines (CLSI document EP9-A2 for Accuracy, CLSI document EP5-A2 for Precision, and Class II Special Controls Guidance Document for Carryover) which likely define these specifications. The reported performance is qualitative, stating that the device "demonstrated equivalent performance" or was "within specification."

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

• Test Set Sample Size: Not explicitly stated. The "Accuracy" study mentions "Patient Samples," but the number of samples used is not provided.
• Data Provenance: Not explicitly stated. The document describes the device preparing "human whole blood," implying human samples were used, but the country of origin is not mentioned. The studies appear to be prospective, laboratory-based evaluations.

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

This information is not provided in the document. The studies listed (Accuracy, Precision, Carryover) are performance assessments of the automated system itself, not studies relying on interpretation by experts to establish a "ground truth" for diagnostic purposes. The ground truth for these types of studies would likely be objective measurements or comparisons against established manual methods or reference instruments.

4. Adjudication Method for the Test Set:

This information is not provided. As noted above, the studies are performance assessments, not expert-opinion-based diagnostic studies.

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

An MRMC comparative effectiveness study was not conducted. This type of study typically involves human readers interpreting diagnostic images or data, and the BD FACS™ Sample Prep Assistant III is an automated sample preparation device, not an interpretive diagnostic tool.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance assessment was done. The studies listed (Accuracy, Precision, Carryover) are evaluations of the device's performance in preparing samples. The "results" section directly refers to the "SPA III" or "SPA III with the BD FACSCalibur system" demonstrating equivalent performance or being within specification, indicating that the device's automated functions were assessed directly.

7. Type of Ground Truth Used:

The type of ground truth used would be based on objective measurements and comparisons against established reference methods.

• For Accuracy, the "Method Comparison and Bias Estimation" likely compared results from samples prepared by the SPA III to results from samples prepared by a predicate device or a manual, gold-standard method.
• For Precision, the ground truth would be statistical measures of reproducibility and repeatability based on replicate measurements.
• For Carryover, the ground truth would be the absence or minimal presence of analytes from a high-concentration sample in a subsequent low-concentration sample, measured objectively.

8. Sample Size for the Training Set:

This information is not applicable or not provided. The BD FACS™ Sample Prep Assistant III is an automated pipetting and diluting system. It is not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Its functionality is based on pre-programmed protocols and mechanical precision, not learned patterns from data.

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

This question is not applicable as the device does not utilize a training set in the context of AI/machine learning. Its "ground truth" for operational accuracy and precision would be established through engineering specifications, calibration, and validation against known standards during its development and manufacturing.

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COULTER TQ-Prep Workstation: Intended to prepare leukocytes from whole blood for In Vitro Diagnostic (IVD) Use when used with the COULTER ImmunoPrep Reagent System and cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indication for Use: Pipetting of ImmunoPrep Reagent System (lyse, stabilizer, and fixative reagents) to samples prepared either manually or with the COULTER PrepPlus 2 sample preparation device to achieve lysis of whole blood samples. Use of COULTER TQ-Prep with cleared Beckman Coulter flow cytometers is described in each application's Instructions for Use. For In Vitro Diagnostic Use Only.

COULTER PrepPlus 2: Intended Use: The COULTER PrepPlus 2, when used in combinations with the COULTER TQ-Prep Workstation, is intended to prepare human whole blood for In Vitro Diagnostic (IVD) Use with cleared Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. Indications for Use: Pipetting blood, cleared Beckman Coulter IVD reagents and Flow-Count Fluorospheres to prepare samples for flow cytometric analysis. Use of the PrepPlus 2 with cleared Beckman Coulter flow cytometers is described in each application Instructions for Use. For In Vitro Diagnostic Use Only.

The COULTER TO-Prep Workstation is used with the COULTER ImmunoPrep Reagent System to prepare leukocytes from whole blood for measurement on flow cytometers. The COULTER PrepPlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.

The provided document describes the K130253 510(k) submission for the COULTER TQ-Prep Sample Preparation Workstation and COULTER PrepPlus 2 Workstations. These devices are intended for preparing human whole blood for in vitro diagnostic use with specific Beckman Coulter IVD applications on cleared Beckman Coulter flow cytometers. The submission focuses on demonstrating substantial equivalence to predicate devices through performance studies.

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

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the test sets in the accuracy, precision, gravimetrics, or carryover studies.

Regarding data provenance, the document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It only mentions that the studies were conducted to support the 510(k) submission.

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

This information is not provided in the document. The studies described are performance evaluations of an automated pipetting and diluting system, comparing its dispense accuracy, precision, and carryover to predicate devices or established standards. These types of studies typically do not involve "ground truth" established by human experts in the same way, for example, an image analysis study would. The ground truth here would be the actual dispensed volumes or analytical measurements from the flow cytometers.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given the nature of a pipetting and diluting system, the "truth" is determined by objective measurements (e.g., gravimetric analysis for dispensed volume, flow cytometer readings for accuracy and precision of sample preparation). Adjudication by human experts is not relevant in this context.

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 devices where human readers interpret results, often with and without AI assistance, to assess the impact on diagnostic accuracy. The devices in this submission are automated sample preparation workstations, which do not involve human interpretation of medical images or diagnostic outputs in the manner an MRMC study would evaluate.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies conducted are standalone performance evaluations of the devices (TQ-Prep and PrepPlus 2 workstations). The "performance" being evaluated is the accuracy, precision, and carryover of their automated functions (pipetting, diluting, reagent addition, mixing) as compared to predicate devices or established guidelines (CLSI documents). There is no "human-in-the-loop" aspect to the fundamental performance of these automated systems.

7. The Type of Ground Truth Used

The "ground truth" in these studies refers to:

• For Accuracy and Precision (with reagents): The actual analytical measurements obtained from flow cytometers after sample preparation, which are then compared to results from predicate devices. The assumption is that the predicate devices produce acceptable analytical results.
• For Gravimetrics: The actual weight of dispensed liquids, which directly correlates to the volume dispensed. This is an objective, measurable truth.
• For Carryover: Analytical measurements demonstrating the absence or presence of unwanted sample transfer, using established methods to quantify carryover.

It is not expert consensus, pathology, or outcomes data in the clinical sense, but rather objective technical and analytical measurements.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. These devices are automated workstations, not AI/ML algorithms that typically require a distinct training set for model development. The reported studies are performance validation studies.

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

As these are automated workstations and not AI/ML models in the typical sense, there is no "training set" or "ground truth for the training set" established in the conventional AI/ML context. The devices are programmed with specific operational parameters, and their performance is then validated through the studies described.

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The BD FACSCanto system with BD FACSCanto clinical software when used with the BD FACS Sample Prep Assistant II is intended for use as an in vitro diagnostic device for identification and enumeration of lymphocyte subsets in human cells in suspension using a lyse / no-wash sample preparation method for flow cytometry. This is the same intended use as previously cleared for the BD FACSCanto system with BD FACSCanto clinical software.

Indications for Use:

• Immunophenotyping in clinical laboratories, using previously cleared IVD I assays for flow cytometry that utilize the lyse no-wash sample preparation method.
• Immunophenotyping of lymphocyte subsets including CD3CD8, CD3CD4, CD3 CD16* and/or CD56*, CD3 CD19*, and CD3*.
• For in vitro diagnostic use.
• For use with or without the BD FACS Sample Prep Assistant II.

The BD FACSCanto system with BD FACSCanto clinical software is a flow cytometry system designed for analyzing samples prepared with the lyse / no-wash method. The BD FACS Sample Prep Assistant II is a microprocessor-controlled pipetting and diluting system which automatically prepares whole blood samples using the lyse / no-wash sample preparation method for flow cytometry. Used as an accessory to the BD FACSCanto flow cytometer, the SPA II combines fluidic, optic, robotic, and electronic components to automatically prepare samples for acquisition and analysis with a flow cytometer.

The SPA II pierces the sample tube cap to withdraw sample, aliquots blood and reagent into daughter tubes, and mixes the sample according to preprogrammed or custom protocols. The device also adds lysing solution and automates cleaning protocols. The unit consists of an enclosure, one robotic pipetting module moving in the X/Y/Z axes, a power supply, a central controller unit, fluid pumps, and a barcode reader.

Device Acceptance Criteria and Study Details:

This document describes the acceptance criteria and study findings for the BD FACSCanto system with BD FACSCanto clinical software, specifically when used with the BD FACS Sample Prep Assistant II (SPA II). The device is intended for the identification and enumeration of lymphocyte subsets in human cells.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The provided document does not explicitly state numerical acceptance criteria or specific thresholds for "comparable accuracy," "acceptable system precision," or "acceptable system carryover." These are derived from the interpretation of the study design and the reported conclusions. The predicate device (BD FACSCanto system with manual pipetting) serves as the benchmark for comparison.

2. Sample Size and Data Provenance:

• Test Set Sample Size: Not specified in the provided document. The "Accuracy" study mentions "Patient Samples" but does not provide a number.
• Data Provenance: Not specified. It can be inferred that the studies were conducted by the manufacturer, BD Biosciences, but the country of origin of the data (e.g., patient samples) and whether it was retrospective or prospective are not mentioned.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• Not applicable. The document describes studies for accuracy, precision, and carryover of a sample preparation system, not for diagnostic interpretation by human experts. Therefore, no experts were used to establish ground truth in the context of diagnostic assessment. The "ground truth" for these studies would be derived from the reference methods outlined in the NCCLS guidelines for accuracy and precision, and specific carryover protocols.

4. Adjudication Method (Test Set):

• Not applicable, as no expert adjudication was involved in these performance studies.

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

• No, a MRMC comparative effectiveness study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging devices where human interpretation is a primary component. The BD FACSCanto system is an automated cell counter, and the studies focus on its analytical performance (accuracy, precision, carryover) relative to a manually operated predicate device, not on improving human reader performance.

6. Standalone (Algorithm Only) Performance:

• Yes, a form of standalone performance was assessed. The studies evaluate the performance of the BD FACSCanto system with the automated BD FACS Sample Prep Assistant II (SPA II) as a complete, integrated system. The SPA II itself is an automation component that replaces manual pipetting. The evaluation implicitly defines its "standalone" performance within the context of the overall system's ability to prepare and analyze samples. The comparison is between the automated preparation method and the manual preparation method using the same core BD FACSCanto system.

7. Type of Ground Truth Used:

• The ground truth for the performance studies would be established using reference methods and guidelines defined by NCCLS (National Committee for Clinical Laboratory Standards) documents EP9-A (Accuracy) and EP5-A (Precision). For carryover, it would be based on Class II Special Controls Guidance Document for Automated Differential Cell Counters. These guidelines provide standardized methods for assessing the analytical performance characteristics of laboratory devices, where "ground truth" is determined by well-controlled experiments and established reference measurements (e.g., highly accurate standard solutions or a gold-standard manual method if applicable, for accuracy studies).

8. Sample Size for the Training Set:

• Not applicable. The provided document concerns the performance evaluation of a device, not the development or training of an AI algorithm on a dataset. Therefore, there is no mention of a "training set" in the context of machine learning.

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

• Not applicable, as no training set for an AI algorithm is mentioned or relevant to the described device and studies.

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The BD Viper"™ instrument is intended for use as a sample processor designed for use with the BD ProbeTec ™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. The BD Viper instrument automates the transfer and mixing of manually prepared and lysed samples. The BD Viper instrument incorporates heating blocks to perform assay priming and prewarming incubation steps prior to the removal and transfer of the microwells to the BD ProbeTec ET instrument for amplification and detection.

The BD Viper is a sample processor designed for use with the BD ProbeTec ET system. The BD Viper automates the transfer and mixing of specimens that have been prepared and lysed according to the specific BD ProbeTec ET assay package insert. Automated specimen transfers by the BD Viper occur from the sample processing tubes to the assay priming microwells and from the priming microwells to the assay amplification microwells. The BD Viper also controls the incubation steps for priming the samples and pre-warming the amplification microwells. After the BD Viper transfers samples from the priming wells to the amplification microwells, the instrument mixes the contents of the amplification microwells. After mixing, the plates are manually sealed and removed from the BD Viper. The sealed plates are placed into the BD ProbeTec ET instrument(s) where the analyte specific amplification and detection process occurs.

The BD Viper is comprised of four major components: robotic pipetting arm, priming and warming heaters, LCD monitor with integrated touch screen, and instrument software.

The BD Viper™ Instrument is a sample processor designed for use with the BD ProbeTec™ ET system and the BD ProbeTec ET Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) assays. It automates the transfer and mixing of manually prepared and lysed samples, and incorporates heating blocks for assay priming and prewarming incubation steps.

Acceptance Criteria and Device Performance

Due to the nature of the device as an automated pipetting and processing system, the acceptance criteria are based on comparative performance to a manual method and the absence of contamination issues. The reported device performance is qualitative, indicating that the automated method performs comparably to or yields substantially equivalent results as the manual method. No specific numerical percentages or thresholds are provided for the acceptance criteria in the summary.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The primary study conducted was a clinical evaluation to demonstrate the "percent agreement" between the BD ProbeTec ET automated method (using the BD Viper) and the BD ProbeTec ET manual method (using the BD ProbeTec ET Pipettor and heating blocks).

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Over 4,000 paired CT and GC results were evaluated.
   • Data Provenance: The study was conducted "internally at two clinical centers," suggesting a prospective clinical study specifically for this device. The country of origin is not explicitly stated but is implied to be the US given the FDA submission.

2. Number of Experts and Qualifications: Not applicable. For this type of instrument performance study comparing an automated method to a manual method for diagnostic assays, expert interpretation of results is generally not the primary endpoint; rather, the agreement of the quantitative or qualitative assay results themselves is assessed. The "ground truth" here is the result obtained by the predicate manual method.

3. Adjudication Method: Not applicable. The study design appears to be a direct comparison of results between two methods (automated vs. manual), not an expert consensus or adjudication of individual cases.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, this was not an MRMC study. This study evaluated the comparative performance of an automated instrument against a manual testing method, not the impact of AI assistance on human readers.

5. Standalone Performance: Yes, the study evaluates the standalone performance of the BD Viper instrument as part of the BD ProbeTec ET system, comparing it directly to the standalone performance of the manual BD ProbeTec ET system. The summary does not describe any human-in-the-loop component for the BD Viper itself; the instrument automates steps that were previously manual.

6. Type of Ground Truth: The "ground truth" for the clinical evaluation was established by the results obtained from the predicate manual method (BD ProbeTec ET System using the BD ProbeTec ET Pipettor). The study aimed to show agreement between the automated and manual results.

7. Training Set Sample Size: The summary does not provide specific details on a separate "training set" for the BD Viper instrument itself. Given that it automates existing assay steps, its development likely involved engineering and calibration rather than a machine learning training paradigm with a distinct training dataset in the same sense as an AI algorithm. The studies mentioned (contamination, environmental, precision, clinical) are primarily for verification and validation.

8. How Ground Truth for Training Set was Established: Not applicable in the context of an AI training set. For the development and validation of the BD Viper, engineering specifications, assay performance characteristics of the manual method, and quality control standards would have guided its design and calibration. The "ground truth" for ensuring its proper functioning would be the established performance characteristics of the BD ProbeTec ET assay itself when performed manually.

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MasterCAP AM 5.0 is a software tool for Assay Management designed to support the set up of an in vitro diagnostic assay run. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x, or Windows '95 Environment.

MasterCAP AM 5.0 handles sample lists, and creates worklists for the related Pharmacia & Upjohn diagnostic equipment. MasterCAP AM 5.0 also evaluates and calculates the assay results and generates laboratory reports. It can import and export results to main frame computers.

MasterCAP AM 5.0 includes a driver function which can send and receive patient data from UniCAP 100 diagnostic equipment.

MasterCAP RM 5,0 is a software tool for Request Management designed to be used together with MasterCAP AM 5.0. MasterCAP RM 5.0 includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP RM can store requests, requestor information and test panels, and also provides backup and restore functions.

1. MasterCAP AM 5.0 is a software tool for assay management designed to support the set up of an in vitro diagnostic immunoassay. It is designed to be used with Pharmacia CAP System diagnostic equipment and related devices. It is run either in Microsoft Windows, 3.x or Windows '95 Environment. The following Pharmacia CAP System diagnostic equipment and related devices may be used with MasterCAP AM: AutoCAP, Positioning Guide 96, RoboCAP Version 2.0, Fluorocount 96, Assay Washer 96, UniCAP 100.

When using the UniCAP 100 Device Driver Function of MasterCAP AM with UniCAP 100, you can transfer sample list data to, and import evaluated assay results from, one or more connected UniCAP 100 devices.

MasterCAP AM 5.0 software directs the diagnostic equipment to perform the following functions:

• import sample lists from a main frame computer or enter the information manually

• • create an assay run
• • distribute samples and tests
• • process an assay
• • collect raw data
• • evaluate and calculate the results
• • export the results to the main frame computer
• • define assay methods and method groups

2. MasterCAP RM 5.Q is a software tool for Request Management designed to be used with MasterCAP AM 5.0 for laboratories running in vitro diagnostic assays. MasterCAP RM includes a database and provides features for request management and data storage. MasterCAP RM handles requests and creates sample lists to be used in MasterCAP AM. When the data are evaluated, MasterCAP RM collects the results and generates a result report for each request. MasterCAP AM and MasterCAP RM are designed to be used with Pharmacia CAP System and UniCAP 100 diagnostic equipment and related devices.

MasterCAP RM can perform the following functions:

• • create sample lists
• • store requests, requester information and test panels
• • create laboratory, result and patient test reports
• • perform database queries
• • provide backup and restore functions

The provided document is a 510(k) summary for the MasterCAP AM 5.0 and MasterCAP RM 5.0 software programs. It primarily focuses on demonstrating substantial equivalence to previously marketed devices and describes the intended use and general features of the software for managing in vitro diagnostic assay runs and requests.

Unfortunately, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or adjudication methods.

The document is a regulatory submission for premarket notification, which describes the device and its intended use to the FDA for a determination of substantial equivalence. It does not typically include detailed performance study data such as those requested in your prompt (e.g., specific performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert consensus, etc.).

Therefore, I cannot populate the table or answer the specific questions about performance studies based on the provided text. The document states that "Several improvements have been made to the updated software resulting in more convenient and versatile software," but it does not quantify these improvements or provide data to support specific performance claims beyond functionality.

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The COBAS AMPLICOR Analyzer is an in vitro diagnostic device intended for use in clinical laboratories for the automation of the AMPLICOR™ Polymerase Chain Reaction test procedures.

The COBAS AMPLICOR is a flexible, automated bench top batch analyzer that automates the amplification and detection steps of the Polymerase Chain Reaction (PCR) process. The COBAS AMPLICOR combines the operations of automated sample handling, reagents deliver, thermal cycling, controlled temperature incubation, photometric detection and result reporting into a single automated analyzer. The instrument consists of five major sub-components: (1) a thermal cycler module; (2) an automated pipeting station; (3) an incubation station; (4) a wash station; and (5) a photometer. An internal computer controls and monitors the major components includingsystem and run control, input/output, communication, results calculaton, and system diagnostic tests.

Here's a breakdown of the acceptance criteria and study information for the COBAS AMPLICOR™ Analyzer, based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical targets (e.g., minimum sensitivity or specificity values). Instead, the primary acceptance criteria focused on demonstrating substantial equivalence to an existing, legally marketed device, particularly the Roche AMPLICOR Chlamydia trachomatis Test performed with separate components. The performance characteristics were evaluated through a precision study and a clinical comparison study.

The core claim is that the COBAS AMPLICOR Analyzer, when used with the COBAS AMPLICOR Chlamydia trachomatis Test, performs equivalently to the manual AMPLICOR Chlamydia trachomatis Test using a Perkin-Elmer 9600 thermal cycler and a Bio-Tek EL800 plate reader.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

• Chlamydia trachomatis Spiked STM (IFU/PCR):
  • 0 IFU/PCR: Mean Absorbance 0.004, Total CV 117.6% (high due to very low mean value)
  • 1 IFU/PCR: Mean Absorbance 3.856, Total CV 3.7%
  • 10 IFU/PCR: Mean Absorbance 3.685, Total CV 5.9%
  • 50 IFU/PCR: Mean Absorbance 3.639, Total CV 5.4%
• Kit Controls:
  • Negative: Mean Absorbance 0.004, Total CV 97.0% (high due to very low mean value)
  • Positive: Mean Absorbance 3.831, Total CV 7.0%
    Interpretation: Shows good reproducibility for positive samples across different operators and days, while very low absorbance negative samples show higher CV due to proximity to zero. |
    | Clinical Performance | Comparative Clinical Performance vs. Predicate Device (AMPLICOR MWP) (See Table 3 in source document):
• Cervical Specimens (266 total):
  • COBAS AMPLICOR Pos & AMPLICOR MWP Pos: 34
  • COBAS AMPLICOR Pos & AMPLICOR MWP Neg: 1
  • COBAS AMPLICOR Neg & AMPLICOR MWP Pos: 1
  • COBAS AMPLICOR Neg & AMPLICOR MWP Neg: 230
• Male Urethral Specimens (93 total):
  • COBAS AMPLICOR Pos & AMPLICOR MWP Pos: 16
  • COBAS AMPLICOR Pos & AMPLICOR MWP Neg: 1
  • COBAS AMPLICOR Neg & AMPLICOR MWP Pos: 0
  • COBAS AMPLICOR Neg & AMPLICOR MWP Neg: 76
• Male Urine Specimens (280 total):
  • COBAS AMPLICOR Pos & AMPLICOR MWP Pos: 63
  • COBAS AMPLICOR Pos & AMPLICOR MWP Neg: 4
  • COBAS AMPLICOR Neg & AMPLICOR MWP Pos: 5
  • COBAS AMPLICOR Neg & AMPLICOR MWP Neg: 208
    Statistical analysis (McNemar's Test) found P > 0.4 for each specimen type, providing strong evidence of no significant difference in positive and negative results between the two test procedures. |
    | Substantial Equivalence | The document concludes that the COBAS AMPLICOR Analyzer (with the COBAS AMPLICOR Chlamydia trachomatis Test) provides substantially equivalent analytical and clinical performance to the predicate device. This is based on the precision data and the non-inferiority demonstrated in the clinical comparison. |

Study Details

1. Sample Size used for the Test Set and the Data Provenance:

   • Precision Study (Non-Clinical):
     • Sample Size: 27 replicates for each of the 6 sample types (0, 1, 10, 50 IFU/PCR spiked samples, negative kit control, positive kit control). Total of 162 tests.
     • Data Provenance: Not explicitly stated, but likely laboratory-generated and prospective (performed specifically for the study).
   • Clinical Performance Study:
     • Sample Size: 639 clinical specimens.
       • 266 endocervical swabs
       • 93 male urethral swabs
       • 280 male urine specimens
     • Data Provenance: Not explicitly stated, but implies clinical samples (from patients). It's specified as "The clinical data reported here were obtained using the AMPLICOR Chlamydia trachomatis Test" implying retrospective use of existing clinical data, or prospective collection of samples that were then tested by both methods. Given the direct comparison side-by-side, it's more likely a prospective collection but doesn't explicitly state "prospective."

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

   • Precision Study: No external "ground truth" experts were used. Ground truth was defined by the spiked concentrations of C. trachomatis IFU/PCR in the samples and the kit controls.
   • Clinical Performance Study: The "ground truth" was established by the AMPLICOR microwell assay (predicate device), which served as the comparator. No specific number or qualifications of experts for reading "ground truth" are mentioned, as the comparison was between two assays. However, it's noted that "Two samples were culture positive/MOMP positive; three samples were culture negative/MOMP positive" in the footnotes of Table 3. This indicates that independent methods (culture, MOMP) were used as additional references for discordant results, but not as the primary ground truth for the overall comparison.

3. Adjudication method for the test set:

   • No explicit adjudication method (like 2+1 or 3+1) is mentioned, as the studies did not involve subjective human reader interpretation of images or complex data needing consensus. The studies compared quantitative measurements (absorbance) and qualitative results (positive/negative) from an automated system with a predicate device.
   • For the discordant results in the clinical comparison (e.g., COBAS AMPLICOR Pos/AMPLICOR MWP Neg), the footnote suggests culture and MOMP positivity were used for reference, but it doesn't describe a formal adjudication process.

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, an MRMC comparative effectiveness study was not done. This device (COBAS AMPLICOR Analyzer) is an automated in vitro diagnostic (IVD) instrument, not an AI-powered image analysis tool or decision support system intended to assist human readers. Its purpose is to perform laboratory tests automatically, replacing manual laboratory procedures. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply to this submission.

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

   • Yes, the studies focused on standalone performance. The COBAS AMPLICOR Analyzer is itself a standalone automated system.
     • The precision study evaluated the intrinsic reproducibility of the automated system.
     • The clinical performance study evaluated the output (qualitative result) of the COBAS AMPLICOR system against the output of a manually-performed predicate test. Both are "algorithm only" in the sense that they produce a result based on a defined protocol, though the COBAS AMPLICOR automates more steps.

6. The type of ground truth used:

   • Precision Study: Defined concentrations of C. trachomatis (IFU/PCR) spiked into transport medium, and certified kit controls.
   • Clinical Performance Study: The predicate device (AMPLICOR microwell assay) was used as the comparator, effectively serving as the "ground truth" for the comparison of substantial equivalence. For specific discordant cases, culture positivity and MOMP (Major Outer Membrane Protein) positivity were used as additional, higher-tier references.

7. The sample size for the training set:

   • Not applicable/Not mentioned. The COBAS AMPLICOR Analyzer is an automated instrument performing a defined chemical/molecular assay, not a machine learning or AI model that requires a "training set" in the conventional sense of algorithm development. The development of the instrument itself would involve engineering validation, but not a data-based "training set" like an AI product.

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

   • Not applicable, as there was no "training set" for an AI or machine learning model.

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UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the 1. measurement of allergen specific IgE in human serum or plasma. UniCAP Specific IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.
2. UniCAP 100 is a fully integrated and automated instrument including software for immunodiagnostic testing. UniCAP 100 is a user friendly instrument designed to handle all steps from sample and reagent handling to processing of results.
3. UniCAP 100 RM External Software is intended to be used with a Windows-based PC operating up to five UniCAP 100 instruments. The external software creates requests and assay runs, retrieves the test results from the instrument, and prints reports. It can also import requests from, and export requests to. a connected mainframe computer or network server.
4. Pharmacia Specific IgE Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE and Pharmacia CAP System™ RAST® RIA/FEIA.
5. Pharmacia Specific IgE Negative Control is intended for laboratory use in monitoring the performance of specific IgE measurements as determined by UniCAP™ Specific IgE, Pharmacia CAP System™, RAST® RIA/FEIA and Phadebas RAST® RIA/FEIA and Phadebas RAST®/Phadezym®.

UniCAP is a fully integrated and automated system for the determinantion of specific IgE in human blood serum or plasma. The UniCAP system includes the UniCAP 100 instrument with software for immunodiagnostic testing; UniCAP reagents, in this submission reagents for the measurement of allergen specific IgE; UniCAP RM External Software; and Pharmacia Specific IgE positive and negative Controls.

The UniCAP 100 instrument is designed to handle all steps from sample and reagent handling to processing of results. Reagents, requests, samples and ImmunoCAP are loaded into the instrument and the process, which takes 2.5 hours is started. A laboratory report is automatically printed when the process is ended.

UniCAP 100 can store a calibration curve to be used for up to one month. After an initial calibration curve is accepted by the software, subsequent assay runs may use the stored calibration curve for calculation of results. In these runs, Curve Controls are included to validate that the run is on the same response level as the stored curve. Limits for the response of the Curve Controls are defined in the UniCAP 100 Operator and Panel Software. A new calibration curve is run once a month, and/or when a new lot number of Specific IgE Conjugate is introduced.

Here's an analysis of the provided text regarding the UniCAP 100 device and its acceptance criteria, structured according to your request:

K962274: UniCAP 100 Specific IgE Assay and Instrument

This submission describes the UniCAP 100 system, an automated in-vitro diagnostic system for the determination of specific IgE in human serum or plasma. It seeks to demonstrate substantial equivalence to the previously cleared Pharmacia CAP System.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied through the comparison study's objectives. While explicit numerical acceptance criteria (e.g., "must be greater than X%") are not stated as such, the reported performance serves as the basis for demonstrating substantial equivalence.

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

• Sample Size: More than 7,000 patient samples.
• Data Provenance: Not explicitly stated regarding country of origin. The study is a retrospective comparison as it uses existing patient samples to compare the performance of the new device (UniCAP 100) against an already established device (Pharmacia CAP System).

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

This information is not provided in the document. The "ground truth" in this context is established by the results from the predicate device (Pharmacia CAP System RAST FEIA), not by a panel of human experts interpreting the results.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Since the comparison is between two automated systems, there is no explicit adjudication method involving human experts. The comparison relies on the numerical outputs and classification of both systems.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is an automated in-vitro diagnostic system for specific IgE measurements, not an AI-assisted diagnostic tool for image interpretation or similar tasks that would typically involve human readers. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

Yes, a standalone performance evaluation was implicitly done. The entire comparison study assesses the UniCAP 100 system (instrument and reagents) as a standalone automated system (algorithm only, without human intervention in the result generation process) against another standalone automated system. The reported percentages are for the device itself.

7. The Type of Ground Truth Used

The "ground truth" in this comparison study is the results obtained from the predicate device, the Pharmacia CAP System RAST FEIA. The UniCAP 100's performance is measured by its agreement with the existing, cleared system, establishing substantial equivalence rather than absolute biological truth (e.g., pathology or long-term outcomes).

8. The Sample Size for the Training Set

The document does not specify a separate training set. The descriptions focus on the comparison study performed with "more than 7,000 patient samples." It's possible that the "training" (e.g., calibration and optimization) of the UniCAP 100 was done internally by the manufacturer prior to this comparison study, but details about such a training set are not included in this summary.

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

Since a dedicated training set is not explicitly described, the method for establishing its "ground truth" is not provided. If an internal development/optimization phase occurred, it would likely have also relied on comparison to established methods or clinical samples, but this is speculative given the provided text.

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