(32 days)
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative in vitro diagnostic determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems
- Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the in vitro diagnostic quantitative determination in human citrated plasma of:
- Prothrombin Time (PT) on IL Coagulation and ELECTRA Systems
- Fibrinogen on IL Coagulation Systems only
The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy (OAT).
Here's an analysis of the provided text, extracting the requested information about device acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly defined by the "substantially equivalent" claim to predicate devices, particularly regarding performance metrics like slope and correlation coefficient (r) in method comparison studies, and Coefficient of Variation (CV) for precision. The reported device performance is directly given by the study results.
| Study Type | Acceptance Criteria (Implicit) | Reported Device Performance (HemosIL RecombiPlasTin) |
|---|---|---|
| Method Comparison (Prothrombin Time) | Slope and 'r' values indicating substantial equivalence to Hemoliance® RecombiPlasTin. Ideal values would be a slope near 1 and an 'r' near 1. | |
| ACL 9000 | (Implicitly compared to predicate device K925604) | Slope: 0.90, r: 0.993 |
| ACL Futura | (Implicitly compared to predicate device K925604) | Slope: 0.99, r: 0.995 |
| E1400C | (Implicitly compared to predicate device K925604) | Slope: 0.95, r: 0.996 |
| Method Comparison (Fibrinogen) | Slope and 'r' values indicating substantial equivalence to IL Test™ PT-Fibrinogen. Ideal values would be a slope near 1 and an 'r' near 1. | |
| ACL 9000 | (Implicitly compared to predicate device K862301) | Slope: 1.00, r: 0.933 |
| ACL Futura | (Implicitly compared to predicate device K862301) | Slope: 1.10, r: 0.957 |
| Within Run Precision (Prothrombin Time) | % CV values for control plasmas indicating acceptable precision. No explicit numerical threshold is given, but single-digit CVs are generally considered good. | |
| ACL 9000 | (Implicitly acceptable based on industry standards for diagnostic devices) | Level 1: 0.8% CV, Level II: 2.5% CV, Level III: 1.7% CV |
| ACL Futura | (Implicitly acceptable based on industry standards for diagnostic devices) | Level 1: 1.1% CV, Level II: 1.2% CV, Level III: 1.1% CV |
| E1400C | (Implicitly acceptable based on industry standards for diagnostic devices) | Level 1: 0.9% CV, Level II: 1.9% CV, Level III: 2.1% CV |
| Within Run Precision (Fibrinogen) | % CV values for control plasmas indicating acceptable precision. No explicit numerical threshold is given. | |
| ACL 9000 | (Implicitly acceptable based on industry standards for diagnostic devices) | Level 1: 4.3% CV, Low Fibrinogen: 3.6% CV |
| ACL Futura | (Implicitly acceptable based on industry standards for diagnostic devices) | Level 1: 4.5% CV, Low Fibrinogen: 9.8% CV |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Method Comparison: 180 citrated plasma samples (100 normal donors and 80 abnormal patient samples).
- Within Run Precision: Three levels of control plasmas for PT and two levels for Fibrinogen. The exact number of replicates for each level is not specified, but it's "over multiple runs."
- Data Provenance: The document does not explicitly state the country of origin. It mentions "human citrated plasma." It is a retrospective study as it uses collected plasma samples.
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 in the document. The "ground truth" here is the measurement obtained from the predicate devices, not an expert consensus on a clinical outcome or image interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as the study involves quantitative measurements against predicate devices, not an expert review or classification task that would require an adjudication method.
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
This information is not applicable. This device is a diagnostic reagent for in-vitro testing of blood components (Prothrombin Time and Fibrinogen), not an AI-powered image analysis or diagnostic aid for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the studies described are standalone performance studies for the device (reagent) in conjunction with specified laboratory systems (ACL 3000, ACL Futura, ELECTRA 1400C). There is no "human-in-the-loop" component in the direct measurement of PT or Fibrinogen in this context.
7. The Type of Ground Truth Used
The ground truth used for the method comparison studies is the measurements obtained from the predicate devices:
- K925604 Hemoliance® RecombiPlasTin for Prothrombin Time.
- K862301 IL Test™ PT-Fibrinogen for Fibrinogen.
For the precision studies, the ground truth is implicitly the true value of the control plasmas, as determined by the manufacturer of those controls or accepted reference methods.
8. The Sample Size for the Training Set
This information is not provided. The concept of a "training set" typically applies to machine learning algorithms. For a diagnostic reagent like HemosIL RecombiPlasTin, there isn't a "training set" in the same sense, as its performance relies on its chemical formulation and interaction with the analytical system, rather than being "trained" on data. The studies described are performance verification/validation studies.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).