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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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