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Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intend for use in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.

Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBSAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid.
Wortham Laboratories Intrin-SI APTT Reagent is a liquid stable extract of rabbit brain thromboplastin, containing stabilizers and buffers. Intrin-SI is an in-vitro diagnostic reagent intended for use for the performance of a citrated Partial Thromboplastin Time (APTT) testing and quantitative PTT-based factor assays for Factors XII, XI, IX and VIII.
Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Fibrinogen Normal Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine proteins (Factor IIa).
Wortham Laboratories Fibrinogen Assay Set contains a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers, buffers, and a bovine reagent and buffer solution which are also provided in the set. Each unit of source material used in the preparation of the control has been tested by an EDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Heparin Control Level 1 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Heparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodics to HIV and HCV.
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Fibrinogen Buffer : 1.3% TAPSO Buffer. 0.9% sodium chloride, 0.1% sodium azide and stabilizers; pH 7.35 ± 0.05.

The provided text describes 12 distinct devices from Wortham Laboratories, each with its own acceptance criteria and study findings. Due to the volume, I will provide a detailed breakdown for the first device, Stasis 1 Coagulation Control (Normal), and then summarize the general approach for the others as they follow a similar pattern.

Device: Wortham Laboratories Stasis 1 Coagulation Control (Normal)

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for Wortham Laboratories Stasis 1 Coagulation Control (Normal) are implicitly established by demonstrating comparable or superior performance to the predicate device, Pacific Hemostasis Coagulation Control Level I. The reported device performance is presented in terms of Coefficient of Variation (CV%) for precision.

Note: The acceptance criteria are "performance equal to or better than the predicate" for most quantitative metrics, and "same" for qualitative metrics like intended use and assay factors. The tables above directly compare the new device's performance to the predicate's stated performance, indicating the new device met or exceeded the predicate's precision values.

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

The document mentions "Mechanical assays of Stasis 1 to the predicate normal plasma control" and "Mechanical measurements of the APTT in both Stasis 1 and Pacific Hemostasis Level 1 Control," along with "The processing of the Fibrinogen levels in both study graphs."

• Sample size: Not explicitly stated as a number of individual samples or runs for the test set. The data is presented as statistical measures (standard deviation, CV%) which are derived from a series of measurements, implying repeated testing.
• Data provenance: Not explicitly stated. The context suggests that the testing was performed by Wortham Laboratories, likely internally. It does not provide information about the country of origin of the data or if it was retrospective or prospective. The source material for the control is "liquid stable citrated plasma obtained from healthy donors," but this refers to the control product itself, not the clinical data.

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

This information is not provided. The "ground truth" for this device appears to be the quantitative measurements obtained from the predicate device (Pacific Hemostasis Coagulation Control Level I) and the established ranges for PT, APTT, and Fibrinogen in normal plasma. The comparison is against established quantitative performance metrics of a legally marketed predicate, not against expert consensus on a clinical outcome.

4. Adjudication method for the test set:

Not applicable. This is a comparison of quantitative laboratory performance metrics of a new control product against an existing predicate control. There is no human adjudication of diagnostic outcomes involved.

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

Not applicable. This is a medical device for in-vitro diagnostic quality control, not an AI-assisted diagnostic tool interpreted by human readers.

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

Not applicable. This device is a quality control product, not an algorithm. Its performance is measured directly by laboratory instruments (e.g., fibrometer).

7. The type of ground truth used:

The ground truth or reference standard for comparison is the performance characteristics of a legally marketed predicate device (Pacific Hemostasis Coagulation Control Level I). The "Expected Range" values are based on "Mechanical Mean ± 2SD," implying statistically derived ranges from repeated measurements, rather than pathology, expert consensus on images, or true outcomes data for individual patients.

8. The sample size for the training set:

Not applicable. This device is a quality control product, not an AI/ML algorithm that requires a training set.

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

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

Summary for other devices (Stasis 2, Stasis 3, Serathan-B PT Reagent, Serathan-A PT Reagent, Intrin-EA APTT Reagent, Intrin-SI APTT Reagent, Fibrinogen Control Plasma (Low), Fibrinogen Control Plasma (Normal), Thrombin Reagent, Fibrinogen Assay Set, Heparin Control Plasma Level 1, Heparin Control Plasma Level 2, Calcium Chloride Solution 0.02 M, Fibrinogen Buffer):

All other devices described in the document (Stasis 2, Stasis 3, Serathan-B, Serathan-A, Intrin-EA, Intrin-SI, Fibrinogen Controls, Thrombin Reagent, Fibrinogen Assay Set, Heparin Controls, Calcium Chloride Solution, Fibrinogen Buffer) follow a very similar pattern to Stasis 1 Coagulation Control.

• Acceptance Criteria and Reported Device Performance: This is consistently established by comparing the new device's performance metrics (primarily Coefficient of Variation (CV%) and standard deviation (SD) for precision, and expected ranges) directly against a specific predicate device's reported performance. The new device consistently demonstrates comparable or improved precision compared to its respective predicate.
• Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Size, and Training Set Ground Truth:
  • Sample Size: Not explicitly stated as the number of individual tests or samples; reported as statistical measures (SD, CV%) derived from repeated measurements.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied internal testing by Wortham Laboratories.
  • Experts/Adjudication/MRMC/Standalone: Not applicable to these types of in-vitro diagnostic quality control and reagent products, as they are evaluated based on quantitative laboratory performance against chemical/biological standards or predicate product performance, not human diagnostic interpretation.
  • Ground Truth Type: For all these devices, the ground truth for evaluation is the established performance characteristics of the legally marketed predicate device, as well as the expected physiological/clinical ranges for the assays they control or participate in (e.g., normal/abnormal PT/APTT/Fibrinogen values).
  • Training Set: Not applicable, as these are not AI/ML algorithms.

The overall conclusion for all devices is a claim of "substantial equivalence" to their respective predicates based on comparable intended use, technological characteristics, and performance data consistently showing competitive or superior precision and expected ranges.

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The Dade Behring Heparin Calibrator is an in vitro diagnostic product used to calibrate the Berichrom® Heparin assay for the measurement of unfractionated heparin. Dade Behring Heparin Controls are in vitro diagnostic products intended to be used as assayed, unfractionated heparin quality control materials for the Berichrom® Heparin assay.

Dade Behring Heparin Calibrator and Controls are lyophilized products prepared from citrated human plasma and contain unfractionated heparin from a porcine source. The kit consists of a calibrator and two levels of assayed controls intended to monitor the performance of Berichrom® Heparin reagent when testing for unfractionated heparin using coagulation analyzers.

Here's a breakdown of the acceptance criteria and study information for the Dade Behring Heparin Calibrator and Controls, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on the performance characteristics demonstrating equivalence and doesn't explicitly list "acceptance criteria" in a typical table format for all parameters. However, it does describe the performance that met the criteria.

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

• Sample Size: The document states that the stability data used "at least duplicate determinations." For the method comparison studies, it mentions "different dilutions of USP Heparin Sodium Reference Standard were spiked into citrated plasma samples." The exact number of samples or dilutions is not specified.
• Data Provenance: The data appears to be from a prospective study conducted by the manufacturer, Dade Behring Inc. The country of origin of the data is not explicitly stated, but the manufacturer is based in Newark, Delaware, USA.

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

• This device is a calibrator and control material for an in vitro diagnostic assay. The ground truth for this type of device is typically established through a reference standard rather than expert interpretation of images or clinical data.
• The study used the USP Heparin Sodium Reference Standard to establish the true heparin concentrations. Therefore, there were no "experts" in the traditional sense required to establish the ground truth for the test set.

4. Adjudication Method for the Test Set

• Given that the ground truth was established by a reference standard, an adjudication method is not applicable in this context. The measurements were quantitative and compared against known values derived from the reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• No. This is an in vitro diagnostic device (calibrator and control) and not an AI-powered diagnostic tool for image interpretation or similar tasks requiring human readers. Therefore, an MRMC study is not relevant aquí.

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

• Yes, effectively. The performance evaluation described is for the device (calibrator and controls) used with coagulation analyzers (Dade Behring BCS® Analyzer and Sysmex® CA-1500 Analyzer). The "performance" of the calibrator and controls is assessed in their ability to correctly calibrate and monitor the assay. There isn't a human-in-the-loop scenario described; the evaluation is of the analytical performance of the products themselves in combination with the specified instrumentation.

7. The Type of Ground Truth Used

• The ground truth used was reference standard data, specifically the USP Heparin Sodium Reference Standard. This standard was used to:
  • Spike known concentrations of heparin into plasma samples.
  • Establish the calibration curve against which the new calibrator's performance was evaluated.

8. The Sample Size for the Training Set

• The document does not provide information about a "training set" for the calibrator and controls. These are standardized materials, and their development typically involves extensive characterization and formulation work rather than machine learning training sets. The studies described are validation (test set) studies to demonstrate performance.

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

• Not applicable, as a "training set" in the machine learning sense is not mentioned or implied for this type of in vitro diagnostic product. The fundamental "ground truth" for the calibrator's development would ultimately trace back to primary reference materials and methods for unfractionated heparin, though specifics are not detailed here.

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Control Plasma N is assayed for use as an accuracy control of the following parameters in the normal range: Prothrombin time (PT); Activated partial thromboplastin time (aPTT); Thrombin time (TT); Batroxobin time; Fibrinogen; Coagulation factors II, V, VII, VIII, VWfF IX, X, XI, XII and XIII ; Inhibitors: Antithrombin III, Protein C, Protein S, as -antiplasmin, C, inhibitor: Plasminogen; Total complement activity**, Lupus anticoagulants. (* Not for BFT ™II analyzer, ** Not available in the U.S.)

Control Plasma N is a Iyophilized control prepared from pooled human plasma. stabilized with HEPES buffer solution. It is an assayed control intended to monitor and evaluate the precision and accuracy of coagulation and fibrinolysis tests in the normal range.

The provided text describes a 510(k) modification for "Dade Behring Inc. Control Plasma N." This product is a control plasma used to monitor the precision and accuracy of coagulation and fibrinolysis tests. The study described focuses on the stability of the control plasma.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states, "In duplicate determinations, reconstituted stability data met the acceptance criteria..." This indicates that the test for stability was performed in duplicate, meaning each stability condition was tested twice.

• Sample Size: "Duplicate determinations" (implies n=2 for each condition tested).
• Data Provenance: The document does not specify the country of origin of the data. Given the manufacturer is Dade Behring Marburg GmbH (Germany) and the contact is Dade Behring Inc. (USA), the testing could have occurred in either location or a combination. The study is prospective as it's testing the stability of the device under defined conditions.

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

This type of study (stability testing of a control plasma) does not typically involve human experts establishing a "ground truth" in the same way as, for example, a diagnostic imaging study. The "ground truth" here is the assigned values of the control plasma, which are determined through standardized assays and extensive validation by the manufacturer, likely involving laboratory scientists and statisticians. The document does not provide details on this process or the number/qualifications of individuals involved in establishing these assigned values.

4. Adjudication Method for the Test Set

Not applicable. As this is a quantitative analytical measurement (recovery within assigned values), there is no "adjudication method" in the sense of expert review or consensus. The results are compared directly against predefined acceptance limits.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a stability study for a laboratory control, not a diagnostic device involving human interpretation of cases. Therefore, an MRMC comparative effectiveness study is not applicable.

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

Yes, in a sense. The "device" (Control Plasma N) itself is a chemical reagent. Its performance is evaluated through laboratory assays. The "standalone" performance here refers to the Control Plasma N maintaining its intended characteristics (i.e., its concentrations/activity of various analytes) over time under specified storage conditions, as measured by standard laboratory tests. There is no "algorithm" in the context of image analysis or AI, but the performance is measured purely instrumentally/analytically without human intervention influencing the concentration results.

7. The Type of Ground Truth Used

The ground truth used here is the assigned values for each parameter (e.g., PT, aPTT, Fibrinogen, etc.) in the Control Plasma N. These assigned values are established by the manufacturer through rigorous testing using reference methods and/or calibrated instruments to determine the expected concentration or activity of each analyte within the control. The stability test then verifies if the values obtained after storage remain within acceptable limits of these assigned ground truth values.

8. The Sample Size for the Training Set

Not applicable. This is a stability study for a control plasma, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set. The "assigned values" for the control material (which serves as the "ground truth" for the stability study) are established by the manufacturer through extensive characterization and validation of the product, typically involving multiple lots and rigorous measurement protocols, prior to its use as a control in other assays. The document doesn't detail this process for the assigned values themselves, only their use in the stability test.

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Reference Check is recommended for use in controlling the accuracy of quantitative hemostasis assays Reference Check is recommended for use in controlling the following parameters in the normal range:

• Fibrinogen .
• Factor II .
• Factor V .
• Factor VII .
• Factor VIII:C
• vWF: antigen ●
• vWF: Ristocetin Cofactor ●
• Factor IX ●
• Factor X .
• Factor XI .
• Factor XII .
• Factor XIII ●
• Prekallikrein .
• Protein C: antigen ●
• Protein C: activity ●
• Protein S: activity .
• Protein S: total .
• Protein S: free .
• Antithrombin: activity ●
• Antithrombin: antigen .
• Alpha-2-antiplasmin .
• Plasminogen .

Reference Check is citrated human plasma collected from 20 or more carefully screened normal donors. Plasmas are pooled, buffered using 0.01M HEPES buffer, aliquoted and rapidly frozen.

The provided text focuses on the 510(k) summary for "Reference Check," a normal control plasma, and strongly emphasizes its substantial equivalence to a predicate device, "Control Plasma N (K001256)." The information details the device's characteristics and its intended use for controlling the accuracy of quantitative hemostasis assays. However, it does not contain the specifics of a study proving the device meets acceptance criteria in the manner of a typical AI/ML device submission. Instead, the "study" is an argument for substantial equivalence.

Based on the provided text, here's an attempt to answer your questions, highlighting where information is absent for this type of medical device submission:

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

The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device. The performance is described in terms of its characteristics and intended use being similar to the predicate.

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

This information is not provided. The submission focuses on comparing the characteristics of the Reference Check product to a predicate device rather than presenting a performance study with a test set of data. The device itself is derived from "citrated human plasma collected from 20 or more carefully screened normal donors."

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 information is not provided. As this is a control plasma and not an AI/ML diagnostic device analyzing complex data, the concept of "experts establishing ground truth for a test set" does not directly apply in the usual sense. The "ground truth" for a control plasma is its assigned values for the analytes it controls, which would be established through laboratory methods and standardization.

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

This information is not provided. Adjudication methods are typically relevant for studies involving human interpretation (e.g., of medical images) where discrepancies need resolution. This is not applicable to a control plasma product.

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

There was no MRMC study conducted. This type of study is relevant for AI/ML diagnostic tools that assist human readers, which Reference Check is not.

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

There was no standalone performance study in the context of an algorithm. Reference Check is a physical laboratory reagent, not an algorithm. Its "standalone" performance would be its stability, consistency, and assigned values, which are inherent to its manufacturing and quality control.

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

The ground truth for a control plasma would be the assigned values (ranges) for the various analytes (e.g., Fibrinogen, Factor II, Protein C activity) determined through standardized laboratory assays. The document states both products are "assayed and provide reference ranges."

8. The sample size for the training set

This information is not applicable/provided. There is no "training set" in the context of a manufactured control plasma. Its characteristics are determined by the pooled human plasma used in its production.

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

This information is not applicable/provided. As above, there's no training set. The "ground truth" (assigned values) for the product is established through rigorous laboratory testing and calibration methods during its manufacture. The device description mentions it is "citrated human plasma collected from 20 or more carefully screened normal donors," indicating the source material for establishing its normal range.

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Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.

Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Coagulation Control Level 1 (Normal) device:

1. Table of Acceptance Criteria and Reported Device Performance

The device is a Coagulation Control (Level 1, Normal) and its performance is assessed based on precision (between-run and within-run) for Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) assays, and the expected range for Fibrinogen. The acceptance criteria are implicitly derived from the "substantially equivalent" claim to the predicate device (Dade Ci-Trol Coagulation Control Level 1). The study demonstrates that the Pacific Hemostasis device falls within similar precision limits and expected Fibrinogen ranges as the predicate.

Notes on Acceptance Criteria: The document directly states that "For both controls a CV of less than 2.0% was obtained for PT and APTT between-run testing" and "The average CV's obtained for within-run precision were less than 1.5% for PT testing, and less than 1.0% for APTT testing of both products." These statements are presented as observed performance but implicitly serve as the benchmark for substantial equivalence.

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

• Test Set Sample Size:
  • Between-run Precision: 20 duplicate measurements over a 10-day period. This means 20 measurements for PT and 20 for APTT for both the Pacific Hemostasis product and the Dade product.
  • Within-run Precision: 3 runs of 20 duplicate measurements. The average %CV is reported. This implies 60 original measurements for PT and 60 for APTT for both products to calculate the average.
  • Fibrinogen: The sample size for Fibrinogen is not explicitly stated in terms of number of measurements, but a single representative value (287 mg/dL for Pacific Hemostasis and 268 mg/dL for Dade) is given.
• Data Provenance: The document does not explicitly state the country of origin of the data. However, the applicant (Pacific Hemostasis) is based in Huntersville, NC, USA. The study is a prospective performance study conducted specifically for this premarket notification.

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

This type of study for a coagulation control material does not typically involve human experts establishing a "ground truth" in the way a medical image diagnosis aid would. The "ground truth" here is the performance characteristics of a known, legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1) and the established normal ranges for PT, APTT, and Fibrinogen in a laboratory setting.

4. Adjudication Method for the Test Set

Not applicable. This is a laboratory performance study of a control material, not a clinical study requiring adjudication of diagnoses or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This study is focused on the device's analytical performance (precision and expected range) compared to a predicate device, not on human reader performance with or without AI assistance.

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

Yes, this is essentially a standalone performance study of the coagulation control material. The device itself (the control plasma) is being evaluated for its inherent analytical characteristics (precision and consistency), not as an algorithm or with human interaction once the test is set up.

7. The Type of Ground Truth Used

The "ground truth" is established by:

• The known, validated performance characteristics of the legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1).
• Clinically accepted normal ranges for PT, APTT, and Fibrinogen assays, which the control is designed to fall within.

8. The Sample Size for the Training Set

Not applicable. This is a premarket notification for a control material, not a machine learning model that requires a training set. The "development" of the product would have involved internal testing and formulation, but not in the context of a "training set" for an algorithm.

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

Not applicable, as there is no training set mentioned or implied for this device.

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Sigma Diagnostics ACCUCOLOR™ High Calibrator is for use with the Sigma Diagnostics ACCUCOLOR™ Antithrombin III (AT-III) to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

This product is designed for use with Accucolor Antithrombin III Assay Kit (CRS117A). The normal range of plasma Antithrombin III (AT-III) has been reported from 79-125% in Plasma 1-234 A normal population range determined at Sigma Diagnostics (n=70) was 83-119% (mean 101.1+9.8). This product provides a reference material with an assigned value slightly above the normal range.

This 510(k) summary primarily focuses on establishing substantial equivalence for the "Accucolor High Calibrator" to a previously marketed device, "Sigma Product A7432." The document does not describe a full performance study with acceptance criteria in the typical sense for a new diagnostic device. Instead, it relies on demonstrating that the new calibrator is equivalent to an existing, cleared calibrator.

Here's an analysis based on the provided text, addressing the requested points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set: Not applicable in the context of a de novo performance study for the calibrator. The primary "study" is a demonstration of substantial equivalence.
• Normal Population Range Determination: A normal population range was determined at Sigma Diagnostics using n=70 samples. The provenance of this data (e.g., country of origin, retrospective/prospective) is not specified, but it was performed "at Sigma Diagnostics." This appears to be a historical determination of a reference range, not a test set for the calibrator.

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

• Not applicable. There isn't a "test set" in the sense of clinical samples being evaluated by experts to establish ground truth for the calibrator's performance. The calibrator itself is part of the measurement system's ground truth by providing a known standard.
• The ground truth for the value assignment of both the new and predicate calibrators relies on traceability to a "WHO International Reference Preparation for Antithrombin III," which implies an internationally recognized standard.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication process for a test set is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• Not applicable. This is not an AI/imaging device.

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

• Not applicable. This is an in vitro diagnostic calibrator, not an algorithm. Its performance is intrinsic to its chemical properties and assigned value.

7. The Type of Ground Truth Used

• The ground truth for the assigned value of the calibrators (both the new and predicate) is established through traceability to a WHO International Reference Preparation for Antithrombin III. This is an internationally recognized reference standard.
• For the normal population range mentioned, the ground truth was derived from a study of n=70 individuals, defining a normal range (83-119% with a mean of 101.1+9.8).

8. The Sample Size for the Training Set

• Not applicable. There is no training set in the sense of a machine learning algorithm.

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

• Not applicable. There is no training set. The "ground truth" for the calibrator's value is established by its manufacturing process and traceability to an international reference standard.

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