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510(k) Data Aggregation
(405 days)
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(30 days)
For determination of resistance to activated Protein C, caused by the Factor V:Q506 (Factor V Leiden) mutation, in plasma from untreated individuals and from patients on oral anti-coagulant (OAT) or heparin therapy.
The APC resistance phenotype is, in more than 90% of cases, due to a mutation in the Factor V gene, resulting in a replacement of Arg506 (R) with Gln (Q) in the Factor V protein. The selectivity for the Factor V:Q506 or other mutations in the Factor V gene rendering the protein resistant to inactivation by APC is increased by normalizing the concentrations of other plasma proteins involved in formation and regulation of thrombin. By performing the APTT-based APC resistance assay in the presence of an excess of Factor V Reagent Plasma, the sensitivity and specificity for the Factor V:Q506 mutation is significantly increased. Further, this modification allows for the analysis of plasma from patients who are on OAT. Sample plasma is prediluted with Factor V Reagent Plasma and incubated with the APTT reagent for a standard period of time. Coagulation is triggered by the addition of CaCl2 in the absence and presence of APC and the time of clot formation is recorded.
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(466 days)
The Athelas Home is indicated for the quantitative determination of white blood cells (WBC) and Neutrophil percentages (NEUT%) in capillary whole blood from fingerstick for patient self-testing with results viewable by healthcare professionals, and in capillary or K2EDTA venous whole blood for multiple-patient use in point-of-care settings. For self-testing, the Athelas Home is intended to be used by a single person and should not be shared. The Athelas Home is only to be used with Athelas Test Strips. The Athelas Home is intended for adult patients (aged 21 and older) at risk of neutropenia. For self-testing patients with psychiatric conditions, clinical judgment should be exercised when deciding the end-user and based on the instructions for use (IFU), the treating physician should determine which patients are competent to perform the test by themselves. Results obtained with the Athelas Home should not be the sole basis for patient diagnosis, treatment, or management of leukopenia and neutropenia, and all results should be evaluated by a healthcare provider. Prescription Use Only.
The Athelas Home is identical to the Athelas Home (K200828) and Athelas One (K181288) in its technology, core software, the analytes measured, all components, and usage process.
The Athelas Home is an automated diagnostic device intended to perform tests on whole blood samples collected in K2EDTA or capillary finger stick samples collected directly into the Athelas test strip. Athelas Home returns quantitative WBC and Neut% metrics from the blood sample. The Athelas Home system is for In Vitro Diagnostic use and for prescription use only.
The Athelas Home is only to be used with Athelas Test Strips. The Athelas Home is indicated for use by patients and caregivers within home settings and at Point-of-Care settings with results viewable by health care professionals. The Athelas Home is indicated for adult populations only (aged 21 and older).
The Athelas Home is not indicated to completely replace a patient's monitoring regimen on reference lab systems. Prescribers should continue monitoring patients using traditional lab-based means as deemed necessary and possible.
The Athelas Home is not indicated to directly diagnose or assist in disease management. Rather, the Athelas Home should be used to quantify WBC and Neut% only, with all decision making owned by the health care professional as per standard of care.
The Athelas Home uses image processing and microfluidics in order to measure WBC and NEUT% values from whole blood in point-of-care and home settings. A drop of blood is placed on the Athelas test strip either directly from the finger or via pipette from K2EDTA whole blood tube. The device uses single-use, disposable test strips, ensuring there is no direct patient contact or contamination with the device itself.
The Athelas Home test strip stains and creates a monolayer of the blood sample within the chamber. The strip is inserted into the test strip slot of the Athelas Home device where a built-in camera captures images of the sample. The images are automatically transmitted to the cloud server where they are processed and analyzed by an image processing algorithm. The quantitative results of WBC, NEUT% results are based on the concentrations and types of cells present in the sample.
Here's a breakdown of the acceptance criteria and study information for the Athelas Home device, based on the provided FDA 510(k) clearance letter:
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (WBC) | Reported Device Performance (Neut%) |
|---|---|---|
| WBC Precision: | ||
| - 7.5% CV above 2K/µL WBC | Within-run Precision/Reproducibility: 2.20 K/µL (5.87% CV), 3.75 K/µL (5.46% CV), 4.12 K/µL (5.09% CV), 5.11 K/µL (5.96% CV), 7.89 K/µL (4.82% CV), 10.01 K/µL (5.45% CV), 14.64 K/µL (4.69% CV), 17.52 K/µL (4.34% CV), 23.33 K/µL (5.81% CV). All met. | |
| - 0.25 K/µL SD below 2K/µL WBC | Not explicitly detailed for each sample below 2K/µL, but overall "All results met the predefined specifications (CV%) for precision." "Overall reproducibility levels were found to meet the acceptance criteria of 7.5% CV for WBC." (Implicitly including SD for lower range). Low-level QC (2.746 K/µL) showed a SD of 0.153 K/µL. | |
| WBC Bias/Error: | ||
| - ±7.5% error above 2K/µL WBC | Method Comparison: -2.31% Mean % Bias (1.1 - 23 K/µL range). Satisfied. | |
| - ±0.25 K/µL error below 2K/µL WBC | Not explicitly detailed for each sample below 2K/µL. | |
| Neutrophil % Precision: | ||
| - 5% SD OR 15% CV | Within-run Precision/Reproducibility: Not explicitly detailed for each sample, but overall "All results met the predefined specifications...for precision." (Implicitly including Neut%). | |
| Reproducibility (Overall Summary Table - Low): 2.680 SD (5.278% CV) Within-run. Total SD 3.443 (6.780% CV). Satisfied. | ||
| Reproducibility (Overall Summary Table - Medium): 3.015 SD (6.030% CV) Within-run. Total SD 3.344 (6.689% CV). Satisfied. | ||
| Reproducibility (Overall Summary Table - High): 2.967 SD (5.838% CV) Within-run. Total SD 3.316 (6.525% CV). Satisfied. | ||
| Neutrophil % Bias: | ||
| - ±10% bias or ±5% Neut% total error (whichever larger) | Method Comparison: 1.18% Mean % Bias (8 - 92.89% range). Satisfied. | |
| At-Home Precision (WBC) | At-Home Precision Repeatability: 5.4% CV (combined patient blood and QC material). Pass (Evaluation Criteria: 7.5% CV). | |
| At-Home Precision (Neut%) | At-Home Precision Repeatability: 1.2% SD (combined patient blood and QC material). Pass (Evaluation Criteria: 5% SD or 15% CV). | |
| Linearity (WBC) | R² = 0.997, Slope = 1.013, Intercept = 0.0449, CVr = 5.08% as per OLS regression. Demonstrated to be linear from lower limit to upper limit and within measured allowable max % diff for each interval. | |
| Flagging Accuracy | % Positive Agreement (Sensitivity): 90.91%. % Negative Agreement (Specificity): 96.71%. % Overall Agreement: 94.87%. Met the specification of >= 90%. | |
| Matrix Comparability (WBC - venous vs capillary) | WBC: Slope 1.026 (1.000, 1.055), Intercept -0.145 (-0.319, 0.018), Mean Bias 0.056 K/µL, Mean % Bias -0.588. Met all evaluation criteria. | |
| Matrix Comparability (Neut% - venous vs capillary) | Neut%: Slope 0.999 (0.938, 1.058), Intercept 0.457 (-2.502, 3.614), Mean Bias 0.162 Percentage Points, Mean % Bias -0.333. Met all evaluation criteria. | |
| At-Home Method Comparison (WBC - Athelas One vs Athelas Home) | WBC: Slope 1.0 (0.95, 1.03), Intercept 0 (-0.16, 0.31), Mean Bias 0, Mean % Bias 0.0. Met all evaluation criteria. | |
| At-Home Method Comparison (Neut% - Athelas One vs Athelas Home) | Neut%: Slope 1.0 (0.98, 1.09), Intercept -1.0 (-6.09, 0.0), Mean Bias -0.5, Mean % Bias 1.3. Met all evaluation criteria. | |
| At-Home Error Rate | Over 94% of tests run successfully with no errors. Errors that were found were resolved after running a single additional test-strip. | |
| At-Home Usability | Large majority of patients found the Athelas Home easy to use and had very little difficulty running the test end to end. (e.g., Lancet use: 32/32 Yes; Test-strip fill: 30/32 Yes; No errors (non-code): 31/32 Yes; App use: 32/32 Yes). | |
| Fill-Volume Testing | Robust to variable volumes of blood. Errors returned for 0µL. Accurate results within bias criteria for 1.4µL, 3.4µL, and 5.4µL fill volumes across various sample concentrations. | Robust to variable volumes of blood. Errors returned for 0µL. Accurate results within bias criteria for 1.4µL, 3.4µL, and 5.4µL fill volumes across various sample concentrations. |
| Device Tilt Testing | Not affected by tilted placement. No significant bias across tilt orientations and samples. All WBC criteria met. | Not affected by tilted placement. No significant bias across tilt orientations and samples. All Neut% criteria met. |
| Device Drop Testing | Robust to drop and vibration schedules. All 12 devices passed functional tests after testing, with no critical physical damage or functional defects, and WBC results remained within reference range. | Robust to drop and vibration schedules. All 12 devices passed functional tests after testing, with no critical physical damage or functional defects, and Neut% results remained within reference range. |
| Device/Test-Strip Temperature Testing | Both device and test-strip continued to meet performance specifications after exposure to extreme temperatures. All WBC bias criteria met. | Both device and test-strip continued to meet performance specifications after exposure to extreme temperatures. All Neut% bias criteria met. |
| Humidity Flex Testing (Test-Strips) | Test-strips continued to function within specifications after exposure to extreme humidity conditions. No evidence of condensation, fill-time within criteria (< 25 seconds), and no color change present for all 8 test strips across schedules. | |
| Vibration Testing | System successfully met evaluation criteria post vibration test. | |
| Cleaning and Disinfection | No change in performance or external materials after 10,000 cleaning and disinfection cycles using Caviwipe. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Bench Testing (Within-run Precision):
- Sample Size: 9 whole blood samples. 10 replicates per sample, per operator, per test strip lot. Total of 90 tests per sample (90 tests x 9 samples = 810 tests).
- Data Provenance: Not specified, but generally from a laboratory setting.
- Bench Testing (Between-run Reproducibility):
- Sample Size: Three levels of ATH-check quality control material (Low, Normal, High). 240 readings per level (2 runs x 20 days x 2 replicates x 3 sites). Total of 720 readings across all levels.
- Data Provenance: Not specified, but implied to be from laboratory/controlled settings across three sites.
- At-Home Precision Study (Patient In-home Whole Blood):
- Sample Size: 24 patients, 2 replicates per patient. Total of 48 individual tests.
- Data Provenance: From at-home users in home environments in the US (implied by "at-home settings in the US" in subsequent sections and the study name).
- At-Home Precision Study (Patient In-home QC Material):
- Sample Size: 10 patients, 3 replicates per patient. Total of 30 individual tests.
- Data Provenance: From at-home users in home environments in the US.
- Linearity:
- Sample Size: 10 samples run in 4 replicates on 4 devices. Total of 160 tests.
- Data Provenance: Samples obtained by pooling "one low WBC concentration fresh whole blood sample one high WBC concentration sample." Generally laboratory prepared samples.
- Interfering Substances:
- Sample Size: Not explicitly stated how many individual samples were spiked and tested for each substance, but a list of 16 substances were tested.
- Data Provenance: Prepared whole blood samples, some naturally occurring, some spiked.
- Reference Intervals:
- Sample Size: 120 healthy donors.
- Data Provenance: Not specified, implied to be based on healthy donors.
- Limit of Blank (LoB):
- Sample Size: 120 total repeated measurements of blank samples.
- Limit of Detection (LoD):
- Sample Size: 2 test strip lots (60 strips each), 5 low-level samples, 2 replicates per sample. Total of 20 low-level tests for LoD calculation (across each lot, 5 samples x 2 replicates).
- Limit of Quantification (LoQ):
- Sample Size: 2 test-strip lots, 1 instrument, 3 days, 3 replicates per sample, 4 independent low-level whole blood samples. Total of 36 low-level tests (4 samples x 3 replicates x 3 days?) + more for the two lots.
- Data Provenance: Distinct whole blood samples acquired from patients in K2EDTA tubes, presumably from a laboratory or clinical setting. Diluted to target concentrations.
- Specimen Stability (Whole Blood):
- Sample Size: 9 different venous blood samples (low, normal, high WBC levels).
- Data Provenance: Venous blood samples.
- Specimen Stability (Test Strip):
- Sample Size: Two test strip lots compared over 26 months, 3 replicates, multiple QC lots. Three replicates per two lots of strips across 3 levels of control fluid run every 60 days.
- Method Comparison:
- Sample Size: 312 patient samples.
- Data Provenance: Taken at 3 point-of-care sites in the US.
- Flagging Comparison:
- Sample Size: 312 samples (same as Method Comparison).
- Data Provenance: Same as Method Comparison (3 point-of-care sites in the US).
- Matrix Comparison (Venous vs. Capillary):
- Sample Size: 59 patients.
- Data Provenance: Capillary finger-prick blood samples and K2EDTA venous whole blood samples from the same patients.
- At-Home Method Comparison:
- Sample Size: 165 samples.
- Data Provenance: Taken in at-home settings in the US.
- At-Home Error Analysis:
- Sample Size: 81 tests (derived from percentages: 76 successful, 3+2+1+1=7 errors, 76/0.94 = 80.85; 7/0.06 = 116.6; approximation derived from given percentages. The actual number is not precisely 81 based on the sum, but implies around this amount.)
- Data Provenance: At-home testing.
- At-Home Usability Analysis:
- Sample Size: 32 users.
- Data Provenance: At-home users during at-home visits.
- Fill-Volume Testing:
- Sample Size: 3 samples tested across 4 fill volumes (0µL, 1.4µL, 3.4µL, 5.4µL). Number of replicates not explicitly stated, but common for such studies.
- Data Provenance: K2EDTA whole blood samples for predicate comparison.
- Device Tilt Testing:
- Sample Size: 3 samples tested across 4 tilt conditions. Number of replicates not explicitly stated.
- Data Provenance: K2EDTA whole blood samples for predicate comparison.
- Device Drop Testing:
- Sample Size: 12 devices.
- Data Provenance: Device testing.
- Device and Test-Strip Temperature Testing:
- Sample Size: Device testing: 3 devices, 9 replicates each, across 3 environmental conditions. Test-strip testing: 3 test-strip lots, 9 replicates each, across 3 environmental conditions.
- Data Provenance: Device and test strips exposed to controlled environmental conditions.
- Vibration Testing:
- Sample Size: Not specified, but refers to "The system".
- Data Provenance: Third party ISTA certified test lab Quanta Testing.
- Humidity Flex Testing:
- Sample Size: 8 test-strips, subject to specified schedules.
- Data Provenance: Test-strips exposed to controlled humidity chambers at Quanta Laboratories.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not explicitly state the number or qualifications of experts used to establish ground truth.
However, it implicitly relies on:
- Predicate devices: The Sysmex XE-5000 and Athelas One are frequently used as the "ground truth" or reference method for comparison. These are legally marketed, validated automated hematology analyzers.
- Clinical Laboratory Standards Institute (CLSI) recommendations: The studies (precision, linearity, LoQ, stability) frequently refer to CLSI guidelines (e.g., CLSI EP05-A3, EP06-A, EP17-A2, EP25-A) as the basis for their methodologies and acceptance criteria, implying adherence to established best practices in laboratory medicine.
- Medical decision levels: The testing was conducted around "medical decision levels," which are established by clinical experts.
- Morphological flagging: This implies comparison against expert (e.g., pathologist, trained medical technologist) review of blood smears, though not directly stated.
Without explicit mention, it's not possible to state "X number of radiologists with Y years of experience," as the device is for hematology, not radiology.
4. Adjudication Method for the Test Set
The document does not explicitly describe an adjudication method for the test set (e.g., 2+1, 3+1, none).
- For method comparison studies, the predicate device (Sysmex XE-5000 or Athelas One) serves as the reference, which performs automated analysis. The "ground truth" is effectively the results from this established, high-accuracy device.
- For flagging comparison, the Sysmex XE-5000's flagging is used as the reference, which would typically be based on its internal algorithms and potentially validated against expert manual differential counts in its own clearance studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The studies focus on the device's analytical performance against predicate devices or its own established metrics, not on how human readers improve with or without AI assistance. The Athelas Home is an automated system providing quantitative results, not an AI-assisted diagnostic aid for human interpretation.
6. Standalone (Algorithm Only) Performance
Yes, the studies primarily describe standalone performance of the algorithm.
- The device captures images, transmits them to a cloud server, where they are "processed and analyzed by an image processing algorithm."
- The results for WBC and NEUT% are "based on the concentrations and types of cells present in the sample" as determined by this algorithm.
- All the performance metrics (precision, bias, linearity, LoD, LoQ, method comparison, flagging) describe the output of the device (i.e., the algorithm and hardware combined) compared to a reference method, without direct human-in-the-loop assistance for interpretation of individual results. Human healthcare professionals evaluate the overall results and provide diagnosis/treatment.
7. Type of Ground Truth Used
- Predicate device measurements: The primary ground truth for quantitative measurements (WBC, NEUT%) was the Sysmex XE-5000 analyzer (a widely accepted automated hematology analyzer) and the Athelas One (the previous generation predicate Athelas device).
- Quality Control (QC) material values: For precision and linearity studies, established values of QC materials (ATH-CHECK) were also used.
- Blank samples: For Limit of Blank.
- Diluted patient samples: For Limit of Quantification.
- Expert consensus/pathology (implied): For flagging comparison and verification of morphological flags, the reference Sysmex XE-5000's flagging implies an underlying ground truth (likely derived from expert manual differentials or pathology review during its own validation), which the Athelas One then compares to. This is not directly stated for Athelas Home validation, however.
- Pre-established reference intervals: For verifying reference intervals against Sysmex XE-5000.
- Outcomes data (No): Not mentioned as a ground truth.
8. Sample Size for the Training Set
The document does not specify the sample size for the training set. It focuses entirely on the validation/test set performance. It mentions that the "images are automatically transmitted to the cloud server where they are processed and analyzed by an image processing algorithm," implying a machine learning component, but provides no details on its development or training data.
9. How the Ground Truth for the Training Set Was Established
As the training set sample size is not specified, neither is the method for establishing its ground truth. However, given the nature of the device (automated cell counter), it would typically involve:
- Expert manual differential counts: Morphological classification and counting of various WBC types on blood smears by highly trained medical technologists or pathologists.
- Reference laboratory analyzer results: Pairing manual counts with results from established automated hematology analyzers for quantitative parameters.
- Annotated images: Images used for training would require meticulous annotation by experts to identify and classify different cell types.
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(268 days)
The Tru Hematology Test is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Hematology Test (part of the TruWellness Panel™) is an in vitro diagnostic device and intended to classify and enumerate WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT, Lymph#, Lymph%, Neut#, Neut%, Other WBC#, and Other WBC% in lithium-heparinized venous whole blood in clinical laboratory or point-of-care settings.
The Tru Hematology Test (part of the TruWellness Panel™) is intended for use in adults 18 years of age or older. It is not intended for use in diagnosing or monitoring critical disease states such as oncology.
The TruSystem is an automated, integrated in vitro diagnostic platform consisting of the Tru Analyzer and the TruWellness Panel™, a Single-Use Consumable Kit that includes a Disc and a Support Pack. Designed for point-of-care and clinical laboratory use, the system enables the simultaneous measurement of clinical chemistry, immunoassay, and hematology parameters from a lithium-heparinized venous whole blood sample in a single run. The TruSystem delivers quantitative results for routine clinical chemistry and immunoassay analytes as well as a complete blood count (CBC) with a 3-part differential, all without the need for specialized operating skills, external calibration, or complex infrastructure.
The Tru Analyzer is a benchtop instrument that fully automates sample processing, assay execution, and result reporting. Its touchscreen interface allows operators to control workflows, initiate tests, and review results with minimal training. The Single-Use Consumable Kit and blood sample are loaded into the analyzer drawer, where all necessary processing takes place. Internally, the Tru Analyzer integrates:
- A high-precision pipettor for automated sample and reagent handling.
- An onboard centrifuge to separate whole blood into plasma.
- A closed-loop thermal control system to maintain precise assay temperatures.
- A motion control system to fully automate sample processing.
- Dedicated detection modules for clinical chemistry, immunoassay, and hematology testing.
- A high-definition camera used to collect assay readings, image capture, and instrument quality control checks.
- An electronics board to manage individual module boards and associated firmware.
- An integrated computer running the instrument software, accessible via the touchscreen user interface.
The Tru Analyzer is factory-calibrated and continuously monitors its performance using optical sensing and electronic feedback mechanisms. Every time the analyzer is powered on or a Single-Use Consumable Kit (TruWellness Panel™) is loaded, the system runs an automated self-test to verify that it remains within calibration and is functioning properly. Internal quality control (QC) checks occur throughout the testing process to ensure the integrity of the analyzer, Disc, and Support Pack. If any self-test or QC check fails to meet system specifications, the Tru Analyzer will display an error code and next steps on the touchscreen interface.
The Single-Use Consumable Kit (TruWellness Panel™) houses all the components needed to process as well as analyze samples on the Tru Analyzer, including dried reagents, internal process control solutions, barcodes that manage the identity of the kit lot (e.g., Disc and Support Pack ID), calibration information, dilution buffers, and single-use plastic pipette tips. It also serves as a waste container which the user discards of at the end of the run.
The Tru Hematology Test is part of the TruWellness Panel™ and is intended for use on the Tru Analyzer. The Tru Hematology Test is an in-vitro diagnostic device intended to classify and enumerate WBC, Lymph # and %, Neut # and %, Other WBC # and %, RBC, HGB, HCT, MCH, MCHC, MCV, and PLT in lithium-heparinized venous whole blood samples.
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(30 days)
HemosIL Silica Clotting Time is intended for the detection of Lupus Anticoagulants in human citrated plasma on the IL Coagulation Systems by the use of screening (SCT Screen) and confirmatory (SCT Confirm) reagents sensitized to phospholipid dependent antibodies.
SCT Screen and SCT Confirm are reagents intended to simplify and standardize the detection of LA in clinical evaluations. SCT Screen is poor in phospholipid making it sensitive to LA. The additional amount of phospholipid in SCT Confirm neutralizes LA to give shorter clotting times.
Silica Clotting Time in the presence of calcium, directly activates the intrinsic pathway of coagulation. SCT Screen and SCT Confirm are therefore unaffected by factor VII deficiencies or inhibitors. Using a ratio of screen and confirm allows the SCT to be insensitive to warfarin treated samples. As a result, SCT Screen and SCT Confirm are more specific tests for the evaluation of LA than APTT or dilute PT. Per CLSI Guideline H-60, patient samples containing heparin may exhibit falsely prolonged clotting times which could lead to incorrect results.
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(28 days)
The CoaguChek XS Plus System is intended for use by professional healthcare providers for quantitative prothrombin time testing for the monitoring of warfarin therapy. The system uses fresh capillary or non-anticoagulated venous whole blood.
The CoaguChek XS Plus system is a portable coagulation monitoring system to monitor prothrombin time (PT) in patients receiving oral anticoagulant therapy. The system uses the amperometric detection of thrombin in the blood sample. A test strip is used to determine a PT value from 8 µL of whole blood. Onboard quality control is available on every test strip and the system also features an optional external quality control material (CoaguChek XS PT Control).
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(26 days)
The iQ200 System is an in-vitro diagnostic device used to automate the complete urinalysis profile, including urine test strip chemistry panel, and microscopic sediment analysis. Optionally, the iQ200 Analyzer can be used as a stand-alone unit, or the results from the iQ200 analyzer can be combined with other urine chemistry results received from an LIS. It produces quantitative or qualitative counts of all formed sediment elements present in urine, including cells, casts, crystals, and organisms. A competent human operator can set criteria for auto-reporting and flagging specimens for review. All instrument analyte image decisions may be reviewed and overridden by a trained technologist.
The iQ200 Series Automated Urine Microscopy system utilizes a specimen sandwiched between lamina layers presented to a microscope with a CCD video camera. This ensures the specimen is precisely within the microscope's focus and field of view. The system automates sample handling and analyte classification for improved data reporting and management. Specimens are aspirated by an autosampler, and individual particle images are isolated in each frame. The Auto-Particle Recognition (APR) software classifies images into 12 categories, and more, with 27 additional sub-classifications available. Particle concentration is determined by the number of images and the analyzed volume. Results are checked against user-defined criteria and sent for operator review or directly uploaded to the LIS. Specimen results can be edited, imported, and exported.
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(111 days)
The QStat Cartridge is a multi-channel cartridge that provides semi-quantitative indications of the coagulation and clot lysis state of a 3.2% citrated venous or arterial whole blood sample using the Quantra Hemostasis Analyzer. The QStat Cartridge includes tests to assess coagulation via the intrinsic and extrinsic pathways and includes a test with tranexamic acid to evaluate clot lysis characteristics.
The QStat Cartridge is intended for in vitro diagnostic use by trained professionals at the point-of-care and in clinical laboratories to evaluate the viscoelastic properties of whole blood by means of the following functional parameters: Clot Time (CT), Clot Stiffness (CS), Fibrinogen Contribution to Clot Stiffness (FCS), Platelet Contribution to Clot Stiffness (PCS), and Clot Stability to Lysis (CSL).
The QStat Cartridge is indicated for the evaluation of blood coagulation and clot lysis in patients age 18 years and older to assess possible hypocoagulable and hypercoagulable conditions in trauma, liver transplantation, and peripartum obstetric procedures.
Results obtained with the QStat Cartridge should not be the sole basis for patient diagnosis.
For prescription use only.
The QStat Cartridge is a single-use, multi-channel disposable plastic cartridge used with the Quantra Hemostasis Analyzer for the evaluation of blood coagulation and clot lysis. The measurements are performed in four test channels of the disposable cartridge which enable differential testing with different sets of reagents without the need for any reagent preparation or controlled pipetting. The cartridge utilizes a citrated evacuated blood collection tube filled with a patient whole blood sample The proprietary technology SEER Sonorheometry measures the evolution of shear modulus (i.e., clot stiffness) in all four channels as a function of time. The QStat Cartridge is intended for use in patients 18 years or older by professionals in a hospital setting (point of care or laboratory) to assess possible hypocoagulable and hypercoagulable conditions in trauma and liver transplantation procedures.
Each QStat Cartridge is pre-filled with lyophilized reagent beads individually sealed in an airtight pouch. After a QStat Cartridge is removed from its primary packaging, it is inserted into the instrument dock. A whole blood sample, collected in a 3.2% sodium citrate anticoagulant blood collection tube (minimum volume 2.7 mL), is attached directly to the cartridge and the test is initiated using the touch screen interface on the Quantra Hemostasis Analyzer. The cartridge is the only component of the Quantra System that is in direct contact with blood. The fluidic system within the instrument draws the sample into the cartridge where it is warmed to 37°C, aliquoted, introduced and mixed with the lyophilized reagents, and analyzed. When the test is complete, the cartridge is released from the dock to be disposed of in an appropriate biosafety sharps container.
The analyzer displays the test results (n=5) in three different views: dial display screen, stiffness curves data, and trend screen. The dial display screen is the primary viewing screen and has a dial for each of the five output parameters. Each dial shows the reference range, assay measurement range, parameter abbreviation, and the numerical result for the corresponding parameter. The stiffness curves are a graphical display of shear modulus measurements over time that enable the user to view the development of clot stiffness over time. The trends screen displays results from a patient for up to six time points.
There are two levels of external QStat Controls (QSL1 and QSL2) that are supplied separately (required but not provided materials) for testing on the Quantra System when changing cartridge lots, changing control lots, or after significant changes are made to the Quantra instrument (e.g., software update).
The FDA 510(k) clearance letter for the Quantra QStat Cartridge describes its intended use for evaluating blood coagulation and clot lysis, specifically extending its indication to peripartum obstetric patients. The submission refers to non-clinical and clinical tests to demonstrate the device meets acceptance criteria.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it describes acceptable performance in relation to interference and clinical agreement.
| Acceptance Criteria (Implied from Study Description) | Reported Device Performance |
|---|---|
| No significant interference from common obstetric medications (hemabate, methergine, misoprostol, oxytocin) | The highest concentration of each substance tested showed no significant interference in whole blood samples collected in 3.2% sodium citrate anticoagulant collection tubes. |
| Clinical agreement between QStat CSL and ROTEM delta EXTEM ML for identifying fibrinolytic samples. | Overall agreement of patient sample assignments into lysis-positive and lysis-negative based on data for QStat CSL and ROTEM delta EXTEM ML was 92%. |
| Correlation between QStat FCS and fibrinogen levels. | Passing-Bablok regression analysis showed good agreement between the methods (slope = 1, r = 0.815), albeit with a constant bias. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Study): 322 subjects
- Data Provenance: Prospective observational study, conducted across seven clinical sites in the US. The study involved parturients (women in labor) aged 18 years or older with concerns for coagulopathy.
- Sample Size (Interference Study): Not explicitly stated with a specific number for the test set, but it mentioned "normal and hypercoagulable whole blood specimens" and that the "number of replicates at each level of a screening study was targeted to provide a 95% confidence interval (2-sided), per CLSI EP07-A2 Guideline."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. Instead, ground truth for some parameters appears to be established by comparison to other legally marketed and established devices (ROTEM delta, TEG 5000) and conventional coagulation testing (aPTT, PT/INR, fibrinogen level, platelet count).
4. Adjudication Method for the Test Set
The document does not describe an adjudication method involving experts for establishing ground truth. The comparison is made against existing, accepted methods and devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any effect size regarding human reader improvement with or without AI assistance. This device is an in vitro diagnostic (IVD) device that measures coagulation parameters, not an AI-assisted diagnostic imaging or interpretation tool.
6. Standalone (Algorithm Only) Performance Study
Yes, the studies described are standalone performance studies. The clinical and analytical specificity studies evaluate the performance of the QStat Cartridge and Quantra Hemostasis Analyzer directly, not in conjunction with human interpretation for the primary measurement. The comparisons are to other standalone diagnostic methods (ROTEM delta, TEG 5000, conventional coagulation tests).
7. Type of Ground Truth Used
The ground truth used for the clinical performance evaluation was based on:
- Comparison to legally marketed viscoelastic testing devices: ROTEM delta or TEG 5000.
- Comparison to conventional coagulation testing: aPTT, PT/INR, fibrinogen level, platelet count.
- The "concern for coagulopathy" as a trigger for testing suggests clinical suspicion as an initial selection criterion, with the aforementioned tests serving as the gold/reference standard for comparison.
8. Sample Size for the Training Set
The document does not provide information about a separate training set or its sample size. The studies described appear to be focused on performance validation.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, there is no information on how its ground truth was established.
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(108 days)
CRYOcheck Chromogenic Factor VIII is for clinical laboratory use in the quantitative determination of factor VIII activity in 3.2 % citrated human plasma. It is intended to be used in identifying factor VIII deficiency and as an aid in the management of hemophilia A in individuals aged 2 years and older. For in vitro diagnostic use.
CRYOcheck Chromogenic Factor VIII is used for determination of FVIII activity and contains the following four components, packaged in glass vials and provided frozen to preserve the integrity of the components:
- Reagent 1: Bovine FX and a fibrin polymerization inhibitor, with activators and stabilizer.
- Reagent 2: Human FIIa, bovine FIXa, calcium chloride and phospholipids.
- Reagent 3: FXa substrate containing EDTA and a thrombin inhibitor.
- Diluent Buffer: Tris buffer solution containing 1% BSA and a heparin antagonist.
In the first stage of the chromogenic assay, test plasma (containing an unknown amount of functional FVIII) is added to a reaction mixture comprised of calcium, phospholipids, human purified thrombin and FIXa, and bovine FX (Reagent 1 and Reagent 2). This mixture swiftly activates FVIII to FVIIIa, which works in concert with FIXa to activate FX. When the reaction is stopped, FXa production is assumed to be proportional to the amount of functional FVIII present in the sample. The second stage of the assay is to measure FXa through cleavage of a FXa-specific peptide nitroanilide substrate (FXa Substrate). P-nitroaniline is produced, giving a color that can be measured spectrophotometrically by absorbance at 405 nm.
Based on the provided FDA 510(k) Clearance Letter, the device in question is the CRYOcheck Chromogenic Factor VIII. This document details the clearance of a modified version of an existing device, emphasizing the differences from the previous version regarding interference claims and recovery of Factor VIII replacement therapies.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for each performance claim in a quantified manner (e.g., "Interference must be less than X%"). Instead, it reports the limits of non-interference found in their studies, implying these served as the de facto acceptance criteria. For the Factor VIII replacement therapy recovery, the acceptance criterion appears to be "accurate evaluation" across a range of concentrations, with specific over/under recovery noted.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Interference: | ||
| Hemoglobin | Must show no interference up to the concentration indicated. | No interference observed up to ≤1000 mg/dL (increased from ≤500 mg/dL) |
| Intralipid | Must show no interference up to the concentration indicated. | No interference observed up to ≤830 mg/dL (increased from ≤500 mg/dL) |
| Bilirubin (unconjugated) | Must show no interference up to the concentration indicated. | No interference observed up to ≤40 mg/dL (increased from ≤29 mg/dL) |
| Bilirubin (conjugated) | Must show no interference up to the concentration indicated. | No interference observed up to ≤11 mg/dL (increased from ≤2 mg/dL) |
| von Willebrand factor | Must show no interference up to the concentration indicated. | No interference observed up to ≤20 µg/mL (same) |
| Unfractionated heparin | Must show no interference up to the concentration indicated. | No interference observed up to ≤3.3 IU/mL (increased from ≤2 IU/mL) |
| Low molecular weight heparin | Must show no interference up to the concentration indicated. | No interference observed up to ≤5 IU/mL (increased from ≤2 IU/mL) |
| Fondaparinux | Must show no interference up to the concentration indicated. | No interference observed up to ≤0.2 mg/L (decreased from ≤1.25 mg/L) |
| Lupus Anticoagulant | Must show no interference up to the concentration indicated. | No interference observed up to ≤1.8 dRVVT ratio (same) |
| Emicizumab | Must show no interference up to the concentration indicated. | No interference observed up to ≤150 µg/mL (new claim) |
| Mim8 | Must show no interference up to the concentration indicated. | No interference observed up to ≤8 µg/mL (new claim) |
| Warfarin | Must show no interference up to the concentration indicated. | No interference observed up to INR ≤7 (new claim) |
| Rivaroxaban | Must not interfere. | Interfered with quantification of FVIII activity. |
| Dabigatran | Must not interfere. | Interfered with quantification of FVIII activity. |
| Recovery of FVIII Replacement Therapy: | Must accurately evaluate potency. | Accurately evaluated potency for ADVATE, ADYNOVATE, AFSTYLA, ALTUVIIO, ESPEROCT, HUMATE-P, JIVI, KOVALTRY, Novoeight, Nuwiq, and wilate at 0.05-1.0 IU/mL; ELOCTATE, and XYNTHA at 0.05-0.6 IU/mL (with over recovery at 0.8 & 1.0 IU/mL); Underestimation for OBIZUR. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Interference Studies: Plasma samples were "spiked with possible interferents," and "10 replicates were tested alongside 10 replicates of the corresponding blank matrix control." The total number of individual patient samples from which this plasma was derived is not specified, nor is the country of origin. The study design implies a prospective spiking experiment in a laboratory setting.
- Recovery of Factor VIII Replacement Therapy: "Congenital FVIII deficient plasma was spiked with 14 FVIII replacement therapies at seven concentrations." The number of individual patient plasma units or lots of deficient plasma used is not specified. The study design implies a prospective spiking experiment in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
N/A. This is an in vitro diagnostic device for quantitative determination of factor VIII activity, not an AI/imaging device requiring expert human readers for ground truth generation. The ground truth for these studies is established by the known concentrations of spiked interferents or FVIII replacement therapies, and the intrinsic properties of the FVIII deficient plasma.
4. Adjudication Method for the Test Set
N/A. As this is a quantitative in vitro diagnostic device, an adjudication method in the context of human expert review of imaging or clinical data is not applicable. The results are measured spectrophotometrically.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC study was not done. This type of study is relevant for AI imaging devices where human readers interpret medical images with and without AI assistance. This document describes an in vitro diagnostic device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Yes, this entire submission describes the standalone performance of the CRYOcheck Chromogenic Factor VIII assay. The device itself performs the quantitative determination of FVIII activity, entirely without a "human-in-the-loop" once the sample is loaded and the assay run according to protocol.
7. The Type of Ground Truth Used
- Interference Studies: The ground truth was the known concentration of the spiked interferent (e.g., Hemoglobin, Intralipid, Bilirubin, etc.) added to plasma samples, and the corresponding blank matrix control.
- Recovery of Factor VIII Replacement Therapy: The ground truth was the known concentration of the spiked FVIII replacement therapy added to congenital FVIII deficient plasma at various concentrations.
8. The Sample Size for the Training Set
N/A. This document describes an in vitro diagnostic assay based on chromogenic principles, not an AI/ML algorithm that requires a "training set" in the computational sense. The device's components (reagents, diluent buffer) and their interaction define the assay, which is then validated through performance studies.
9. How the Ground Truth for the Training Set was Established
N/A. See point 8. The "ground truth" for developing and optimizing such a chromogenic assay would stem from extensive biochemical research, characterization of reagents, and titrations against known standards, which is inherent in the development of any diagnostic assay, but not referred to as a "training set" or "ground truth establishment" in the AI/ML context.
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