Search Results

HemosIL Liquid Anti-Xa is an automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:

• · When used with HemosIL Heparin Calibrators: Quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity on the ACL TOP Family and ACL TOP Family 50 Series.
• · When used with HemosIL Apixaban Calibrators:

Quantitative determination of apixaban on the ACL TOP Family 50 Series through measurement of Factor Xa activity, which is inversely proportional to the apixaban level. With HemosIL Apixaban Calibrators, the assay is intended to measure apixaban concentrations in patients on apixaban therapy in the following situations where measurement of apixaban levels could be useful to have as additional information:

• Patients at risk for major bleeding
• Patients experiencing a bleeding episode

The assay is not a stand-alone test and the results should be used in conjunction with other clinical and laboratory findings.

For use in adult population. For prescription use only.

HemosIL Liquid Anti-Xa is a one stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. The assay provides quantitative results on 3.2% citrated human plasma for the following analytes based on the calibrators used:

. When used with HemosIL Heparin Calibrators:

Heparin levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Heparin Calibrators.

Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the heparinantithrombin complex is formed, two competing reactions take place.

• 1. Factor Xa is neutralized by heparin-antithrombin complex.
• 2. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.

In order to reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture.

When used with HemosIL Apixaban Calibrators: .

Apixaban levels in patient plasma are measured automatically on ACL TOP Family and ACL TOP Family 50 Series when this assay is calibrated with HemosIL Apixaban Calibrators.

Apixaban directly inhibits Factor Xa activity independent of the antithrombin present. The Factor Xa activity measured by the assay is exogenous. Factor Xa is neutralized directly by apixaban.

Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the apixaban level in the sample.

Measurement of apixaban concentration is recommended by the International Society of Thrombosis and Hemostasis Subcommittee on Control of Anticoagulation in certain clinical scenarios including bleeding episodes, perioperative management, and suspicion of overdose.

The provided document is a 510(k) summary for a medical device (HemosIL Liquid Anti-Xa), primarily focused on a specific change: modifying the labeled on-board instrument stability claim from 7 days to 4 days and removing claims for a particular instrument family (ACL Elite/Elite Pro). This type of submission (Special 510(k)) indicates that the core device and its fundamental performance characteristics are already established and the submission is for a minor modification.

Therefore, the document does not contain the information typically found in a clinical study report that would establish the initial acceptance criteria and prove the device meets them from scratch. It refers to a guideline (CLSI EP25-A) for the testing conducted for the stability claim change, but doesn't detail the acceptance criteria for the entire device's performance (e.g., accuracy, precision, linearity, etc., across its full analytical range).

The information requested in the prompt (sample size for test set, data provenance, number/qualifications of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training and test sets) is characteristic of studies for diagnostic devices, particularly AI/software-as-a-medical-device (SaMD) products, where performance is often evaluated against human expert consensus or clinical outcomes. The HemosIL Liquid Anti-Xa is an in vitro diagnostic (IVD) assay, not an AI/SaMD product that requires human expert review of images or signals for ground truth. Its performance validation relies on analytical studies (e.g., accuracy against reference methods, precision, linearity, interference studies).

Based on the provided document, I cannot fulfill most of the requested information because it is not contained within this 510(k) summary.

Specifically, the document:

• Does not provide a full table of acceptance criteria for the device's overall performance (only discusses a change in stability claim).
• Does not discuss aspects like sample size for test sets in the context of clinical performance evaluation against a human-established ground truth, data provenance for such sets, expert numbers/qualifications, or adjudication methods, as these are typically not relevant for an IVD reagent's analytical performance assessment in the same way they are for image-based AI diagnostics.
• Does not mention any multi-reader multi-case (MRMC) comparative effectiveness study, as it's not an AI-assisted diagnostic tool.
• Does not discuss standalone algorithm performance, as it's a reagent for an automated instrument.
• Does not specify the type of ground truth used in the context of human expert review. For an IVD, "ground truth" would typically refer to reference method results or clinical diagnosis established through established laboratory and clinical procedures.
• Does not provide information on training set sample size or how ground truth was established for a training set, as it is not an AI/machine learning device that undergoes a training phase in the typical sense.

The only relevant information that can be extracted regarding a "study" is for the change being submitted:

1. Acceptance Criteria and Device Performance (for On-Board Stability Change):

The document states the study was conducted "based on testing to the current CLSI EP25-A guideline" to support the change in on-board stability from 7 days to 4 days. While it doesn't explicitly list the numerical acceptance criteria for this specific study, the implication is that the data collected over 4 days met the performance specifications (e.g., accuracy, precision) as defined by the CLSI EP25-A guideline for reagent stability. The reported performance is that the device meets the 4-day stability claim, leading to the regulatory approval.

2. Sample Size and Data Provenance for Stability Test: While the specific sample size for the stability study is not detailed, it would involve multiple replicates of control and/or patient samples measured over the 4-day period on the specified instruments (ACL TOP Family and ACL TOP Family 50 Series) stored at 15-25°C. Data provenance would be from internal laboratory studies of Instrumentation Laboratory Co. (the manufacturer). This would be a prospective analytical study designed to assess reagent stability under defined conditions.

3. Number of Experts and Qualifications / Adjudication Method / MRMC Study / Standalone Performance: Not applicable for this type of IVD reagent validation. There are no human experts involved in establishing ground truth for analytical performance, nor is there a multi-reader study or standalone algorithm.

4. Type of Ground Truth Used: For analytical performance like stability, the "ground truth" would be the initial performance of the freshly prepared reagent or its performance compared to a reference method, against which subsequent measurements over time are compared to assess degradation. This is an analytical ground truth, not a clinical ground truth established by human experts.

5. Training Set Sample Size and Ground Truth Establishment: Not applicable. This is an IVD reagent and not an AI/ML device that requires a "training set" in the sense of machine learning. The design and parameters of the assay are established through chemical and biological research and development, not data-driven machine learning.

Ask a specific question about this device

INNOVANCE® Heparin Assay
In vitro diagnostic automated chromogenic assay for the quantitative determination of unfractionated heparin (UFI) and low molecular weight heparin (LMWH) activity in human plasma collected from venous blood samples in 3.2% sodium citrate tubes on the BCS® XP System in the clinical laboratory. For use with plasma from patients undergoing heparin anticoagulant therapy with either UFH or LMWH. The performance of this device has not been established in neonate and pediatric patient populations.

INNOVANCE® Heparin Calibrator
For calibration of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.

INNOVANCE® Heparin UF and LMW Controls
For quality control of the INNOVANCE® Heparin assay for the quantitative determination of the activity of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) in citrated human plasma.

The INNOVANCE® Heparin assay is a one stage chromogenic assay. The reagent kit consists of two components. One component (INNOVANCE Heparin Reagent) contains Coagulation Factor Xa (Xa), the other (INNOVANCE Heparin Substrate) a chromogenic substrate specific for Xa. Upon mixing of INNOVANCE Heparin Reagent and INNOVANCE Heparin Substrate, Xa converts the chromogenic substrate into two products, one of them is paranitroaniline. The formation of paranitroaniline can be quantified by the coaqulation analyzer employing light absorption at a specific wavelength (405 nm). In the presence of a heparin containing sample the formation of paranitroaniline will be reduced in a time dependent manner. This is due to inhibition of Xa by the heparin/antithrombin (AT) complex. This complex is formed in the patient's plasma and competes with the substrate conversion by Xa. The concentration of the complex is not only dependent on the concentration of heparin but also on the availability of the patient's endogenous antithrombin. By comparison to a reference curve the heparin activity of the sample can be quantified. To reduce the influence from heparin antagonists, such as platelet factor 4 (PF4), dextran sulfate is included in the reaction mixture.

The INNOVANCE® Heparin Calibrator consists of 5 calibrator levels. INNOVANCE® Heparin Calibrator 1 represents plasma containing no heparin. INNOVANCE® Heparin Calibrator 2, 3, 4 and 5 contain defined activities of LMWH and are calibrated against the World Health Orqanization (WHO) International Standards for UFH and LMWH. The calibrator levels are used to establish a reference curve (calibration curve) which then can be employed to quantify the heparin activity of UFH and LMWH containing plasmas.

The INNOVANCE® Heparin Controls consist of plasmas containing defined activities of either UFH or LMWH. Recovery of these controls within their assigned ranges indicates proper functionality of the assay system.

This document describes the performance data for the INNOVANCE® Heparin Assay, INNOVANCE® Heparin Calibrator, and INNOVANCE® Heparin UF and LMW Controls. The information provided focuses on the analytical performance of the device rather than a clinical study involving human readers and AI assistance. Therefore, some requested information related to human expert involvement, MRMC studies, and AI-specific ground truth establishment cannot be extracted from this document.

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

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

The document provides extensive data on linearity, specificity (interference), reproducibility, and repeatability. Specific acceptance criteria are mentioned as "pre-established acceptance criteria" or inferred from the "no interference up to..." statements. Since the exact numerical acceptance criteria are not explicitly listed in a consolidated table, I will present the reported performance and note that the studies "met pre-established acceptance criteria" or "were found to cause no interference."

Acceptance Criteria and Reported Device Performance for INNOVANCE® Heparin Assay System

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

• Measuring Range (Linearity): 21 different dilutions per heparin type (UFH and LMWH). Uses plasma pools spiked with standards.
• Specificity (Interference): Base pools of UFH and LMWH were prepared. Specific sample count not provided, but implies multiple samples to establish "no interference up to..." levels.
• Reproducibility and Repeatability:
  • Reagent (reproducibility): 240 measurements (N=240) per sample type (LMW/UF controls, LMWH/UFH plasma pools).
    • Conducted at three external sites and one internal site (Siemens Marburg site prepared pools). Data provided is multicenter.
    • Plasma pools were prepared at Siemens Marburg and sent frozen to external sites, implying retrospective analysis of these prepared samples.
  • Reagent (repeatability): 240 measurements (N=240) per sample type.
    • Conducted at one site (Bad Oeynhausen).
  • Calibrator (reproducibility): 120 measurements (N=120) per calibrator level.
    • Conducted at three internal sites.
  • Calibrator (repeatability): 240 measurements (N=240) per calibrator level.
    • Conducted at one site.
  • Controls (reproducibility): 240 measurements (N=240) per control level.
    • Conducted at three sites.
  • Controls (repeatability): 240 measurements (N=240) per control level.
    • Conducted at one site.
• Frozen vs. Fresh Method Comparison: 69 samples (N=69).
  • Conducted at one study site in Germany.
  • This study involved both fresh samples (measured within 4 hours) and frozen aliquots of the same samples (measured after at least one week of -70°C storage), making it a comparison of sample handling rather than purely retrospective vs. prospective patient data collection.
• Method Comparison (vs. predicate device):
  • UFH samples: 165 samples (N=165).
  • LMWH samples: 155 samples (N=155).
  • Conducted at three sites, including one external US site. All sites used the same protocol.
  • Frozen samples were thawed and measured, indicating a retrospective use of collected samples.

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

This document describes the analytical performance of an in-vitro diagnostic device for quantifying heparin activity. The "ground truth" in this context is established by reference methods, international standards (WHO International Standards for UFH and LMWH), and analytical accuracy/precision measurements, not by human expert interpretations of images or clinical outcomes. Therefore, there are no human experts involved in establishing the "ground truth" as described for medical imaging AI devices.

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

Not applicable. This is an analytical performance study for an in-vitro diagnostic assay. Adjudication methods like 2+1 or 3+1 are typical for subjective human interpretation tasks, such as radiology reads, which are not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document is about an in-vitro diagnostic device, not an AI-assisted diagnostic tool that involves human readers interpreting cases.

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

Yes, the studies presented (linearity, specificity, reproducibility, repeatability, frozen vs. fresh comparison, method comparison) are effectively "standalone algorithm" performance evaluations, as they assess the device's analytical measurement capabilities directly, without human interpretation of results as a variable. The "algorithm" here refers to the biochemical reactions and instrument logic that produce the quantitative heparin activity measurement.

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

The ground truth for this device is based on:

• International Standards: The INNOVANCE® Heparin Calibrators and Controls are traceable to the World Health Organization (WHO) International Standards for UFH and LMWH. This is the primary reference for accuracy and calibration.
• Reference Methods/Predicate Devices: The method comparison studies demonstrate equivalence to an established, legally marketed predicate device (Coamatic Heparin assay on the IL ACL TOP®), which itself would have been validated against accepted reference methods and standards.
• Known Concentrations: Linearity and interference studies use samples spiked with known concentrations of UFH, LMWH, and potential interferents.
• Statistical Analysis: CLSI guidelines (e.g., EP06-A, EP07-A2, EP05-A2, EP09-A3) are used for statistical evaluation of analytical performance, ensuring robust and validated methodologies for assessing precision and accuracy.

8. The sample size for the training set

This document does not specify a "training set" in the context of machine learning. The device is a traditional in-vitro diagnostic assay, not an AI/ML algorithm that undergoes a distinct training phase on a large dataset. The "training" for such devices typically involves the development and optimization of the reagent formulations, instrument parameters, and calibration procedures, which is an engineering and chemistry development process rather than a data-driven training of a model.

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

As there is no "training set" in the AI/ML sense, this question is not applicable. The development and calibration of the assay components (reagents, calibrators, controls) are established through rigorous analytical chemistry and metrology principles, tracing back to international reference standards and validated against known concentrations and predicate devices.

Ask a specific question about this device

The STA® - Liquid Anti-Xa kits are intended for use with STA-R®, STA Compact® and STA Satellite® analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparins by measuring their anti-Xa activity on antithrombin in a competitive assay using a synthetic chromogenic substrate.

The STA® - Multi Hep Calibrator is a set of calibrator plasmas intended for use with STA-R®, STA Compact®, and STA Satellite® analyzers, for the calibration of heparin (UFH and LMWH) activity assay by measuring the anti-Xa activity.

The STA® - Quality HNF/UFH kit is a set of two plasmas intended for the quality control of unfractionated heparin (UFH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact®, and STA Satellite® analyzers.

The STA® - Quality HBPM/LMWH kit is a set of two plasmas intended for the quality control of low molecular weight heparin (LMWH) activity assay by measuring the anti-Xa activity performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The STA® - Liquid Anti-Xa is a chromogenic assay technique used for determination of the level of UFH and LMWH that have high affinity for antithrombin by measuring their anti-Xa activity. The method is a one-step reaction based on a similar principle: as soon as factor Xa is added to the plasma-substrate mixture, two reactions take place simultaneously, namely, hydrolysis of the substrate by factor Xa and inhibition of factor Xa by the heparin-antithrombin complex. After the necessary period of time for the competitive reaction to reach equilibrium, the quantity of paranitroaniline that is released is inversely proportional to the concentration of heparin present in the test medium.

The STA® - Multi Hep Calibrator reagents are lyophilized human plasmas at five different heparin concentrations. They are used to create the calibration curve on STA-R®, STA Compact®, and STA Satellite® analyzers performing the chromogenic method for heparin (UFH and LMWH) using STA® - Liquid Anti-Xa.

The STA® - Quality HNF/UFH reagents are lyophilized human plasmas at two different UFH concentrations. They are used for the quality control of UFH activity assay by measuring the anti-Xa activity using the chromogenic method STA® - Liquid Anti-Xa performed on STA-R®, STA Compact®, and STA Satellite® analyzers.

The STA® - Quality HBPM/LMWH reagents are lyophilized human plasmas at two different LMWH concentrations. They are used for the quality control of LMWH activity assay by measuring the anti-Xa activity using the chromogenic methods, STA® - Liquid Anti-Xa and STA® - Rotachrom® Heparin, performed on STA-R®, STA Compact, and STA Satellite® analyzers.

The provided document describes the 510(k) summary for several in vitro diagnostic devices for measuring heparin activity. The document focuses on demonstrating substantial equivalence to predicate devices through performance characteristics, rather than establishing acceptance criteria and proving them with a specific study with a defined ground truth, as would be common for AI/ML device submissions.

Therefore, many of the requested elements (e.g., test set sample size, data provenance, number of experts for ground truth, adjudication method, MRMC study, training set details) are not applicable or not explicitly detailed in this type of submission.

However, I can extract information related to performance characteristics that serve as "acceptance criteria" for the device, and the studies performed to demonstrate these.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes performance characteristics of the STA® - Liquid Anti-Xa device (and its associated calibrator and controls) through precision and detection limit/working range studies. The "acceptance criteria" are implied by the ranges and values obtained, showing performance similar or superior to predicate devices or within acceptable analytical limits for IVD assays.

• Sample 1 (mean 0.21 IU/mL): Repeatability CV 6.2%, Within-lab CV 9.9%
• Sample 2 (mean 0.55 IU/mL): Repeatability CV 3.1%, Within-lab CV 6.6%
• Sample 3 (mean 0.97 IU/mL): Repeatability CV 3.4%, Within-lab CV 5.5%
  LMWH Samples:
• Sample 4 (mean 0.86 IU/mL): Repeatability CV 3.1%, Within-lab CV 4.8%
• Sample 5 (mean 1.48 IU/mL): Repeatability CV 3.0%, Within-lab CV 5.1%
• Sample 6 (mean 1.75 IU/mL): Repeatability CV 2.9%, Within-lab CV 5.0% | Performed according to CLSI guideline EP5-A2 over 22 days, 2 runs/day. |
  | Precision (Dedicated Calibration - 3-point UFH) | CV% values within acceptable analytical limits. | UFH Samples:
• Sample 1 (mean 0.22 IU/mL): Repeatability CV 5.6%, Within-lab CV 9.2%
• Sample 2 (mean 0.55 IU/mL): Repeatability CV 3.0%, Within-lab CV 6.1%
• Sample 3 (mean 0.97 IU/mL): Repeatability CV 3.5%, Within-lab CV 5.1% | Similar study design to hybrid calibration. |
  | Precision (Dedicated Calibration - 3-point LMWH) | CV% values within acceptable analytical limits. | LMWH Samples:
• Sample 4 (mean 0.86 IU/mL): Repeatability CV 3.2%, Within-lab CV 5.2%
• Sample 5 (mean 1.48 IU/mL): Repeatability CV 3.1%, Within-lab CV 5.3%
• Sample 6 (mean 1.75 IU/mL): Repeatability CV 2.8%, Within-lab CV 5.1% | Similar study design to hybrid calibration. |
  | Detection Limit (UFH/LMWH 5-point calibration) | Detection threshold should be clinically relevant for heparin monitoring. | 0.10 IU/mL (UFH and LMWH) | Assessed according to CLSI guideline EP17-A. |
  | Linearity Range (UFH/LMWH 5-point calibration) | Linearity range should cover the clinically relevant range for heparin monitoring. | UFH: up to 1.10 IU/mL; LMWH: up to 2.00 anti-Xa IU/mL | Assessed according to CLSI guideline EP6-A. |
  | Detection Limit (UFH 3-point calibration) | Detection threshold should be clinically relevant. | 0.10 IU/mL | Assessed according to CLSI guideline EP17-A. |
  | Linearity Range (UFH 3-point calibration) | Linearity range should cover the clinically relevant range. | up to 1.10 IU/mL | Assessed according to CLSI guideline EP6-A. |
  | Detection Limit (LMWH 3-point calibration) | Detection threshold should be clinically relevant. | 0.10 anti-Xa IU/mL | Assessed according to CLSI guideline EP17-A. |
  | Linearity Range (LMWH 3-point calibration) | Linearity range should cover the clinically relevant range. | up to 2.00 anti-Xa IU/mL | Assessed according to CLSI guideline EP6-A. |
  | Interfering Substances | No significant interference from common endogenous substances at clinically relevant concentrations. | Insensitive to: hemoglobin (up to 1.5 g/l), conjugated bilirubin (up to 288 mg/l), unconjugated bilirubin (up to 138 mg/l), triglycerides (up to 6.9 g/l). | Performed according to CLSI guideline EP7-A2. |

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

• Test set sample size: For precision studies, 6 heparin samples (3 UFH, 3 LMWH) were used for each calibration type (hybrid and dedicated). For the detection limit and linearity studies, specific sample numbers are not provided but are implicit in the CLSI guidelines (EP17-A and EP6-A) which typically involve multiple replicates across different concentrations. For interfering substances, the number of samples is not explicitly stated, but the study tested specific concentrations of key interferents.
• Data provenance: Not explicitly stated, but given this is an in vitro diagnostic device for global markets, the samples would likely be prepared laboratory controls and patient plasma samples (for linearity, detection limit, and interference studies), not geographically defined "countries of origin" in the same way as imaging data. The studies are prospective in the sense that they are designed experiments to validate performance.

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

• Not applicable (N/A) in the context of this IVD device. The "ground truth" for these types of assays is established by the known concentrations of calibrators, controls, and spiked samples, or by reference methods, not by expert interpretation.

4. Adjudication method for the test set:

• N/A. Adjudication is not relevant for analytical performance studies of quantitative IVD assays.

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. This is an in vitro diagnostic device, not an AI/ML-driven interpretive device typically associated with MRMC studies.

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

• Yes, this is a standalone device. The performance characteristics (precision, detection limits, linearity, interference) are determined for the algorithm/device only. Human involvement is in operating the analyzer and interpreting the numerical results, but the analytical performance itself is inherent to the device.

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

• For precision, linearity, and detection limit, the ground truth is established by the known concentrations of the calibrators and control plasmas, or by accepted reference methods for heparin activity (e.g., anti-Xa activity).
• For interfering substances, the ground truth is the addition of specific interfering agents at known concentrations to samples, and then assessing if the device's measurement of heparin is accurately maintained.

8. The sample size for the training set:

• Not applicable (N/A) in the AI/ML sense. This is a traditional IVD device using established chromogenic assay principles, not an AI/ML system that requires a "training set" to learn. The method relies on biochemical reactions and quantitative measurement.

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

• N/A for the same reason as point 8.

Ask a specific question about this device

• HemosIL Liquid Heparin: Automated chromogenic assay for the quantitative determination of . unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
• HemosIL Heparin Calibrators: For the calibration of the HemosIL Liquid Heparin assay on IL . Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
• HemosIL LMW Heparin Controls (Assayed): For the quality control of the HemosIL Liquid . Heparin assay when testing for low molecular weight heparin (LMW) on IL Coagulation Systems (ACL TOP® Family, ACL" ELITE/ ELITE PRO®8/9/10000 and ACL Futura/ACL Advance Systems).
• · HemosIL UF Heparin Controls (Assayed): For the quality control of the HemosIL Liquid Heparin assay when testing for unfractionated heparin (UFH) on IL Coagulation Systems (ACL TOP® Family, ACL™ ELITE/ ELITE PRO®/8/9/10000 and ACL Futura/ACL Advance Systems).
  For in vitro diagnostic use.

HemosIL Liquid Heparin .
One stage chromogenic assay based on a synthetic chromogenic substrate and on Factor Xa inactivation. Heparin levels in patient plasma are measured automatically on IL Coagulation Systems.
Heparin is analyzed as a complex with antithrombin present in the sample. The concentration of this complex is dependent on the availability of the patient's endogenous antithrombin. When the Heparin - antithrombin complex is formed, two competing reactions take place.

• 1. Factor Xa is neutralized by heparin-antithrombin complex.
• 2. Residual Factor Xa is quantified with a synthetic chromogenic substrate. The paranitroaniline released is monitored kinetically at 405 nm and is inversely proportional to the heparin level in the sample.
• HemosIL Heparin Calibrators .
  Lyophilized calibrators prepared from human citrated plasma by means of a dedicated process at three different heparin concentrations: 0, 0.8 and 2.0 IU/mL and are traceable to the WHO International Standards for LMW and UF Heparin.
• HemosIL LMW Heparin Controls (Assayed) .
  Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different LMW heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for low molecular weight heparin.
• HemosIL UF Heparin Controls (Assayed) .
  Lyophilized controls prepared from human citrated plasma by means of a dedicated process at two different UF heparin concentrations (low and high) for the assessment of precision and accuracy of the Liquid Heparin assay when testing for unfractionated heparin.

HemosIL Liquid Heparin Assay, Controls, and Calibrators - Acceptance Criteria & Study Summary

This document describes the acceptance criteria and supporting studies for the HemosIL Liquid Heparin Assay, HemosIL Heparin Calibrators, HemosIL LMW Heparin Controls, and HemosIL UF Heparin Controls, as extracted from the provided 510(k) summary (K090209).

1. Acceptance Criteria and Reported Device Performance

The 510(k) submission primarily demonstrates substantial equivalence through method comparison studies and precision assessments. The acceptance criteria for substantial equivalence are implicitly defined by comparing the new device's performance to that of predicate devices and demonstrating acceptable precision.

The following table summarizes the reported device performance, particularly focusing on precision and method comparison results, which serve as the evidence for meeting implied acceptance criteria for assay performance characteristics relevant to quantitative diagnostic devices. Specific, explicit acceptance criteria (e.g., "CV % must be

Ask a specific question about this device

Biophen Heparin is an in vitro diagnostic test for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma using automated or manual methods. The nopant of UFH is determined from the Anti factor Xa (anti-FXa) activity expressed by the [AT* Heparin] complex formed in plasma. Heparin is used for curative or preventive indications. Measuring Heparin concentration in patient's plasma allows monitoring therapy and adjusting drug dosage.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA for a heparin assay device. It does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies typically associated with AI/ML device evaluations. Such information is usually found in the 510(k) summary or full submission, not in the FDA's decision letter.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the given text.

The document primarily states that the device is substantially equivalent to a predicate device for the quantitative determination of unfractionated heparin (UFH) activity in human citrated plasma.

Ask a specific question about this device

The Rapidpoint™Coag Enoxaparin Test card (ENOX) is a qualitative test intended for exclusive use with the Rapidpoint Coag analyzer to detect the anticoagulant effects, ≥ 1.0 IU/ml, of the low molecular weight heparin (LMWH), Lovenox®/Clexane® (enoxaparin sodium)¹, in arterial citrated whole blood from patients with unstable angina (UA)/non-ST segment elevation myocardial infarction (NSTEMI) who may transition to percutaneous intervention (PCI). The ENOX test is intended for use at either the point of care or in the central laboratory. The device does not discriminate between values of enoxaparin below 1.0 IU/ml and the absence of drug.

The test provides information on the patient's citrated arterial whole blood response to enoxaparin by measurement of the clotting time using a factor Xa activated clotting method and should be interpreted in conjunction with other clinical data available to the clinician

The RapidPoint Enoxaparin (ENOX) test is a one-step dry coagulation method performed on the RapidPoint Coag analyzer. All of the components necessary to perform the assay, with the exception of patient sample, are included in the reaction chamber of the test card.

In the ENOX test, factor X is rapidly converted to factor Xa by a specific factor X activator initiating the clotting process. Enoxaparin, from the patient's blood, complexes with antithrombin (AT), to inhibit factor Xa and lengthen the clotting time. Reported clotting times in excess of the assay cut-off indicate an enoxaparin concentration greater than or equal to 1.0 International Units per milliliter. The results generated by the ENOX test are indicative of the anticoagulant effect produced by enoxaparin in citrated arterial whole blood.

The test card formulation contains purified Factor Xa activator, calcium, phospholipid and stabilizers. Paramagnetic iron oxide particles (PIOP) are included to provide an optical detection mechanism in the presence of patient sample.

Here's a summary of the acceptance criteria and study details for the Thrombolytic Assessment System (TAS) or Rapidpoint™ Coag Enoxaparin (ENOX) Test Card.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the clinical study's results in relation to the intended use. The device is intended to detect enoxaparin levels ≥1.0 IU/mL. The study uses a clotting time cutoff of ≥ 260 seconds to indicate this.

Ask a specific question about this device

ACTICHROME® Heparin (anti-fila) is a chromogenic assay intended for the quantitative determination of therapeutic heparin in human plasma by measurement of factor IIa (thrombin) inhibition. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

ACTICHROME® Heparin (anti-fIIa) Product No. 820

The provided text describes a 510(k) summary for the ACTICHROME® Heparin (anti-fIIa) assay. It focuses on demonstrating substantial equivalence to a predicate device, primarily through method comparison and precision studies.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a numerical or categorical format for demonstrating substantial equivalence. Instead, it relies on a strong "positive correlation" with the predicate device and acceptable precision (CV%).

Ask a specific question about this device

ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins. The Electra 900C® was used to determine performance data. This kit is for in vitro diagnostic use.

ACTICHROME® Heparin (anti-fXa) is a chromogenic assay intended for the quantitative determination of unfractionated and low molecular weight heparins in human plasma. The assay measures the inhibition of factor Xa (fXa) activity by the various heparins.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACTICHROME® Heparin (anti-fXa) device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve an R-value of at least X"). Instead, it presents performance data and implies that equivalence to the predicate device is the overarching acceptance criterion. Thus, the "acceptance criteria" are inferred from the demonstrated performance in comparison to the predicate.

Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device