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The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t (9;22) positive Chronic Myeloid Leukemia (CML) adult patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is a reverse transcription-quantitative PCR performed on the Sniper Digital PCR All-in-One System and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t (9:22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is intended for use only on the Sniper Digital PCR All-in-One System.

The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t (9:22). This test is not intended for the diagnosis of CML.

The BCR-ABL1 (p210) %IS Kit (Digital PCR Method) is designed for detection of the BCR-ABL1 fusion gene (p210) and ABL1 gene, with specific primers and specific fluorescence probes. The test process includes three parts. The first part is to extract ribonucleic acid (RNA) from peripheral blood of CML patients. The second part is to detect BCR-ABL1 fusion gene (p210) and ABL1 internal reference gene in RNA samples by RT-dPCR (Reverse Transcription-Droplet PCR) reaction solution using the Sniper Digital PCR All-in-One System (DQ24-Dx). The third part is to analyze the results.

The Sniper Digital PCR All-in-One System consists of one instrument, which can be used together with it's supporting consumables and BCR-ABL1 (p210) %IS Kit (Digital PCR Method) to complete the detection of samples.

The Sniper Digital PCR All-in-One System divides the sample into about 20000 droplets and carries out PCR amplification, read the number of positive and negative droplets through fluorescent signals, and then calculate the concentration of nucleic acid quantitatively according to the volume of the droplets and the principle of Poisson Distribution.

DQ24-Dx-Sight Software (v1.0.2) is used to control the system and analyze test results. This software is embedded in the Sniper Digital PCR All-in-One System.

Here's a breakdown of the acceptance criteria and study detailed in the provided document:

Acceptance Criteria and Device Performance

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The Xpert BCR-ABL Ultra test is an in vitro diagnostic test for the quantitation of BCR-ABL1 and ABL1 mRNA transcripts in peripheral blood specimens of diagnosed t(9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABLI fusion transcripts type e13a2 and/or e14a2. The test utilizes automated, quantitative, real-time reverse transcription polymerase chain reaction (RT-qPCR). The Xpert BCR-ABL Ultra test is intended to measure BCR-ABL1 to ABL1 percent ratios on the International Scale (IS), and also expressed as a log molecular reduction (MR value) from a baseline of 100% (IS), in t(9;22) positive CML patients during of treatment with Tyrosine Kinase Inhibitors (TKIs).

The test does not differentiate between e13a2/b2a2 or e14a2/b3a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.

The Xpert BCR-ABL Ultra test is intended for use only on the Cepheid GeneXpert® Dx System and the GeneXpert Infinity System.

The Xpert BCR-ABL Ultra test is an automated in vitro diagnostic test for quantifying the amount of BCR-ABLI (BCR-ABL, hereafter) mRNA transcript as a ratio of BCR-ABL/ABL per the International Scale (IS).

The test is performed on the Cepheid GeneXpert® Dx System and GeneXpert Infinity System (referred to as the GeneXpert systems). The GeneXpert systems require the use of single-use, disposable cartridges that hold the PCR reagents and host the PCR process. Because the cartridges are self-contained and specimens never come into contact with working parts of the instrument modules, cross-contamination between samples is minimized. The GeneXpert systems have 1 to 80 randomly accessible modules, depending upon the instrument, that are each capable of performing separate sample preparation and real-time PCR and RT-PCR tests. Each module contains a syringe drive for dispensing fluids (i.e., the syringe drive activates the plunger that works in concert with the rotary valve in the cartridge to move fluids between chambers), and a proprietary I-CORE® thermocycler for performing real-time PCR and RT-PCR and detection.

The Xpert BCR-ABL Ultra test includes reagents to detect BCR-ABL fusion genes resulting from two major breakpoints, translocation e13a2/b2a2 and e14a2/b3a2 and the ABL transcript as an endogenous control in peripheral blood specimens. The amount of BCR-ABL transcript in the patient sample is reported as a percent ratio of BCR-ABL/ABL on the International Scale (IS), and also expressed as a log molecular reduction (MR value) from a baseline of 100% (IS), using the GeneXpert software.

There are two controls included in each Xpert BCR-ABL Ultra test, which are the ABL Endogenous Control and the Probe Check Control (PCC). The ABL Endogenous Control normalizes the BCR-ABL target and ensures that sufficient sample is used in the test. The PCC verifies reagent rehydration. PCR tube filling, and that all reaction components, including probes and dyes, are present and functional in the cartridge.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Xpert® BCR-ABL Ultra

Note: The provided document is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than explicitly stating pre-defined "acceptance criteria" in a quantitative, pass/fail manner. For this analysis, I will infer relevant performance metrics from the non-clinical and clinical studies presented as evidence of substantial equivalence. The "Acceptance Criteria" column will represent the demonstrated performance that FDA found acceptable for classification, and the "Reported Device Performance" will be the specific results from the studies.

1. Table of Acceptance Criteria and Reported Device Performance

• Linear regression R² for e13a2/b2a2 breakpoint.
• Linear regression R² for e14a2/b3a2 breakpoint.
• Maximum Standard Deviation (SD) within reportable range. | - e13a2/b2a2: R² = 0.98304
• e14a2/b3a2: R² = 0.9788
• Maximum SD = 0.26 (within reportable range of MR0.26 to MR4.52) |
  | Analytical Sensitivity (LoD):
• LoD for e13a2/b2a2 breakpoint (target 95% positivity).
• LoD for e14a2/b3a2 breakpoint (target 95% positivity).
• Overall LoD claimed for both breakpoints. | - e13a2/b2a2: 0.0030% (IS)/MR4.52 (95.74% positivity at this level)
• e14a2/b3a2: 0.0029% (IS)/MR4.55 (96.04% positivity at this level)
• Overall LoD: 0.0030% (IS)/MR4.52 |
  | Analytical Sensitivity (LoQ):
• Equivalence to LoD.
• MR Standard Deviation for e13a2/b2a2 and e14a2/b3a2 within defined limits (e.g.,

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The QXDx™ BCR-ABL %IS Kit is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed (9;22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QXDx BCR-ABL %IS Kit is a reverse transcription-quantitative PCR performed on the Bio-Rad QXDx™ AutoDG™ ddPCR System and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in (9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

The QXDx BCR-ABL %IS Kit is intended for use only on the Bio-Rad QXDx AutoDG ddPCR System.

The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9;22). This test is not intended for the diagnosis of CML.

The QXDx AutoDG ddPCR System consists of two instruments, the QXDx Automated Droplet Generator and the QXDx Droplet Reader, and their associated consumables. The QXDx Automated Droplet Generator partitions samples into approximately 20,000 nanoliter-sized droplets and, after PCR on a thermal cycler, droplets from each sample are analyzed individually on the QXDx Droplet Reader. PCR-positive and PCR-negative droplets are counted to provide direct quantification of nucleic acid in digital form. Results are analyzed on QXDx Software running on a Windows based computer.

The QXDx AutoDG ddPCR System contains:

• QXDx Automated Droplet Generator ●
• QXDx Droplet Reader ●
• Laptop Computer with QXDx Software .
• Accessory components: ●
  • o ddPCR Dx AutoDG Consumable Pack
    • Automated Droplet Generation Oil for Probes ■
    • DG32 Cartridges w/ Gaskets ■
    • ddPCR Pipet Tips
    • . ddPCR 96 Well Plates
    • . ddPCR Pierceable Foil Seals
  • o ddPCR Dx AutoDG Droplet Reader Oil Pack

Components of the kit QXDx BCR-ABL %IS KIT:

• QXDXTM BCR-ABL primers & probes
• QXDXTM Nuclease Free Water
• QXDXTM iScript Advanced Reverse Transcriptase
• QXDXTM 5x iScript Select Reaction Mix
• QXDXTM RT Primers
• QXDXTM 2X ddPCRTM Supermix
• QXDXTM BCR-ABL ~0.1%IS
• QXDXTM BCR-ABL ~10%IS
• QXDXTM BCR-ABL Neg-CTRL
• QXDXTM BCR-ABL H-CTRL
• QXDXTM BCR-ABL L-CTRL

The provided document details the analytical and clinical performance of the QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR System. This device is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL and ABL1 transcripts in total RNA from whole blood of diagnosed Chronic Myeloid Leukemia (CML) patients.

The document does not describe the acceptance criteria and study for an AI/ML powered medical device, but rather for an in vitro diagnostic (IVD) kit. Therefore, many of the typical acceptance criteria and study elements associated with AI/ML devices (e.g., human-in-the-loop performance, expert consensus for ground truth on images, MRMC studies) are not applicable.

Below is a breakdown of the acceptance criteria and study details provided for this IVD kit, adapted to the requested format where possible, and noting where specific requested information (relevant to AI/ML devices) is not available for this type of device.

Acceptance Criteria and Reported Device Performance

The core acceptance criteria are related to the analytical performance of the kit, primarily precision, reproducibility, cross-reactivity, interference, linearity, and detection capability. The performance is consistently reported in terms of Molecular Reduction (MR) value or %International Scale (%IS), which are standardized measures for BCR-ABL levels.

Table 1: Acceptance Criteria of the QXDx BCR-ABL %IS Kit and Reported Performance

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The MolecularMD MRDx BCR-ABL Test is an in vitro diagnostic test for the quantitative detection of BCR-ABL 1 transcripts (e13a2/b2a2 and/or e14a2/63a2) and the ABL1 endogenous control mRNA in peripheral blood specimens from patients previously diagnosed with t(9:22) positive chronic myeloid leukemia (CML). The ratio of BCR-ABL1 is calculated and reported on the WHO International Scale. The test utilizes quantitative, real-time reverse transcription polymerase chain reaction performed on the Applied Biosystems 7500 Fast Dx instrument.

The MolecularMD MRDx BCR-ABL Test is intended to measure BCR-ABL mRNA transcript levels in patients diagnosed with t(9;22) positive CML during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

The device is also intended to be used in the serial monitoring for BCR-ABL mRNA transcript levels as an aid in identifying CML patients in the chronic phase being treated with nilotinib who may be candidates for treatment discontinuation and for monitoring of treatment-free remission.

The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion franscripts resulting from t(9:22). The test is not intended for the diagnosis of CML.

The MolecularMD MRDx® BCR-ABL Test is a quantitative, real-time polymerase chain reaction test that provides quantitation of BCR-ABL1 (hereafter BCR-ABL) transcript e13a2/b2a2 or e14a2/b3a2 and ABL1 (hereafter ABL) transcript levels in RNA extracted from peripheral blood samples collected from CML patients. Peripheral blood is collected in either EDTA or PAXgene Blood RNA Tubes. Each collection tube type requires a specified RNA extraction method and RNA input amount. Total RNA is extracted from peripheral blood and serves as the template for RT-qPCR. The test is performed using a onestep RT-qPCR protocol wherein the reverse transcription and quantitative, real-time PCR reactions are performed in the same well. BCR-ABL and ABL amplicons are generated and detected in real-time using TaqMan® MGB probes. The MolecularMD MRDx BCR-ABL Test is performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument. The instrument integrates a thermal cycler, a fluorometer and application specific software. The ABI 7500 Fast Dx instrument software v1.4.1 calculates the BCR-ABL and ABL copy numbers using a standard curve generated with calibrators on each individual plate. The data are exported as a CSV file for further analysis in the MRDx® BCR-ABL Test Software. The BCR-ABL/ABL ratio is calculated and converted to the International Scale by the MRDx BCR-ABL Test Software. The MRDx BCR-ABL Test Software is used to analyze all test results. This software, provided with the MRDx BCR-ABL Test, is used to calculate the BCR-ABL/ABL % IS and MR value for patient sample using the conversion factor for the MRDx BCR-ABL Test after validating each MRDx BCR-ABL Test result against the run acceptance criteria and sample acceptance criteria.

The MolecularMD MRDx BCR-ABL Test is an in vitro diagnostic test for the quantitative detection of BCR-ABL1 transcripts and ABL1 endogenous control mRNA in peripheral blood specimens from patients previously diagnosed with t(9;22) positive chronic myeloid leukemia (CML). It calculates the ratio of BCR-ABL1 to ABL1 and reports it on the WHO International Scale. The device is intended to measure BCR-ABL mRNA transcript levels in CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs). It is also intended for serial monitoring of BCR-ABL mRNA transcript levels to aid in identifying CML patients in the chronic phase being treated with nilotinib who may be candidates for treatment discontinuation and for monitoring of treatment-free remission.

Here's an overview of the acceptance criteria and study data:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a consolidated table of acceptance criteria for all performance characteristics. However, individual acceptance criteria are mentioned within the description of each study. Below is a summary of acceptance criteria and the device's reported performance, extracted from the document:

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The QuantideX qPCR BCR-ABL IS Kit is an in vitro nucleic acid amplification test for the quantitation of BCR-ABL1 and ABL1 transcripts in total RNA from whole blood of diagnosed t(9,22) positive Chronic Myeloid Leukemia (CML) patients expressing BCR-ABL1 fusion transcripts type e13a2 and/or e14a2. The QuantideX qPCR BCR-ABL IS Kit is a reverse transcription-quantitative PCR performed on the Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument and is intended to measure BCR-ABL1 to ABL1, expressed as a log molecular reduction (MR value) from a baseline of 100% on the International Scale, in t(9;22) positive CML patients during monitoring of treatment with Tyrosine Kinase Inhibitors (TKIs).

The test does not differentiate between e13a2 or e14a2 fusion transcripts and does not monitor other rare fusion transcripts resulting from t(9:22). This test is not intended for the diagnosis of CML.

The QuantideX qPCR BCR-ABL IS Kit reagents are adapted for use on the ABI 7500 Fast Dx Real-Time PCR Instrument. The assay includes reagents sufficient for 60 reactions. A description of the reagents provided is described below in Table 1.

Here's a summary of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes both analytical and clinical performance acceptance criteria.

Analytical Performance - Precision/Reproducibility

Analytical Performance - Linearity

Analytical Performance - Limit of Quantitation (LoQ)

Analytical Performance - Interfering Substances

Analytical Performance - Primer Specificity

Analytical Performance - RNA Input

Analytical Performance - Traceability

Analytical Performance - Specimen Stability (Whole Blood)

Clinical Performance

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

The primary test set for clinical performance involved a retrospective study with:

• Sample Size: 137 evaluable samples from 96 subjects (out of 139 samples from 98 patients initially collected).
• Data Provenance: Retrospective, collected at 2 clinical sites in the US (OHSU and Hospital of the University of Pennsylvania).

For analytical performance studies, various sample compositions and quantities were used:

• Precision (within-lab & site-to-site): 25 samples formulated from 5 human RNA specimens positive for BCR-ABL1 diluted into RNAs from CML-negative blood. The site-to-site reproducibility study involved 1200 measurements from this 25-sample pool.
• Linearity/Reportable Range: 2 separate RNA specimens (one e13a2, one e14a2) diluted into RNAs from CML-negative whole blood (ranging from MR 0.1 to MR 4.8).
• Limit of Blank (LoB): 30 non-leukemic human RNA specimens.
• Limit of Detection (LoD): 4 separate human RNA specimens positive for BCR-ABL1, serially diluted to 28 levels.
• Limit of Quantitation (LoQ): 6 specimens derived from 6 human RNA positive for BCR-ABL (diluted to target MR 4.7).
• Interfering Substances: Residual CML-positive blood diluted to approximately MR 4.0 into RNA from CML-negative whole blood (tested in 9 replicates).
• Primer Specificity: 11 leukemic specimens (CML, AML, ALL) and 2 non-leukemic RNA specimens.
• Specimen Carryover Contamination: Serially diluted total RNA from residual clinical CML-positive blood into RNA from CML-negative whole blood in a checkerboard pattern (25 high positive, 25 negative).
• RNA Isolation: CML-positive white blood cells serially diluted across 4 levels (MR 1-4) into CML-negative human anti-coagulated whole blood.
• RNA Input: 30 samples derived from 2 primary RNA samples diluted into non-leukemic human RNA (total 216 evaluable observations).
• Traceability: WHO Reference Panel (4 panel members tested in duplicate).
• Reagent Stability: 5 samples diluted to approximately MR 1, 2, 3, 4, and

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