Search Results

HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family and ACL TOP Family 50 Series of analyzers. The product is intended to be used for the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.

The thromboplastin reagent included in the ReadiPlasTin kit, after mixing with the ReadiPlasTin Diluent, is a liposomal preparation that contains recombinant human tissue factor (RTF), re-lipidated in a synthetic phospholipid blend. In the PT test, the addition of the tissue thromboplastin (ReadiPlasTin reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrin, with formation of a solid gel. The fibrinogen is quantitated (PT-based method) by relating the absorbance or light-scatter during clotting to a calibrator.

The provided text is a 510(k) Summary for a medical device called "HemosIL ReadiPlasTin." This document doesn't describe an AI/ML-based device, but rather an in vitro diagnostic (IVD) reagent used for Prothrombin Time (PT) and Fibrinogen determination. Therefore, many of the requested categories related to AI/ML device testing (e.g., number of experts for ground truth, adjudication method, MRMC study, training set information) are not applicable to this type of submission.

However, I can extract the relevant information regarding acceptance criteria and performance studies for this IVD device.

Here's a breakdown of the requested information, adapted for an IVD reagent:

Device: HemosIL ReadiPlasTin (In vitro diagnostic thromboplastin reagent)
Purpose: Quantitative determination of Prothrombin Time (PT) and Fibrinogen in human citrated plasma.
Reason for Submission (K213426): Reformulation of the existing HemosIL ReadiPlasTin by adding EDTA as a stabilizer and removing unnecessary fillers.

1. Table of Acceptance Criteria and Reported Device Performance

For this IVD, "acceptance criteria" are typically defined by the method validation standards (e.g., CLSI guidelines) and the equivalence to the predicate device. The performance data presented are the results of meeting these criteria.

• PT: UFH (1.0 IU/mL), LMWH (1.4 IU/mL), Hemoglobin (500 mg/dL), Triglycerides (1000 mg/dL), Bilirubin (Conjugated & Unconjugated) (50 mg/dL), Daptomycin (100 µg/mL)
• Fibrinogen: UFH (1.5 IU/mL), LMWH (1.7 IU/mL), Hemoglobin (500 mg/dL), Triglycerides (600 mg/dL), Bilirubin (Conjugated & Unconjugated) (50 mg/dL), Daptomycin (200 µg/mL) | New claims for daptomycin and conjugated bilirubin interference were added. The study used 2 clinical sample levels for both PT and Fibrinogen. |
  | Method Comparison | Strong correlation and agreement between the subject device and the predicate device (HemosIL RecombiPlasTin 2G). Slope should be near 1, intercept near 0, and correlation coefficient (r) close to 1. | ACL TOP Family:
• PT (INR): Slope 1.031 (95% CI 1.009, 1.053), Intercept -0.043 (-0.068, -0.018), r 0.997
• Fibrinogen (mg/dL): Slope 0.975 (95% CI 0.963, 0.986), Intercept 7.171 (3.842, 10.50), r 0.995
  ACL TOP Family 50 Series:
• PT (INR): Slope 1.021 (95% CI 0.999, 1.043), Intercept -0.034 (-0.060, -0.009), r 0.996
• Fibrinogen (mg/dL): Slope 1.015 (95% CI 1.003, 1.027), Intercept -0.811 (-4.148, 2.527), r 0.994 | All method comparison results demonstrated excellent correlation and agreement, supporting substantial equivalence. |
  | Open Vial Stability | Maintain performance for 10 days at 2-8°C in closed original vial after preparation. | "The results support the following labeled open vial stability claim: Once prepared for use, 10 days at 2-8℃ in closed original vial" | Tested across 3 lots per CLSI EP25-A. |
  | On-board Instrument Stability | Maintain performance for 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series after preparation. | "The results support the following labeled on-board instrument stability claim: Once prepared for use, 10 days at 15°C on the ACL TOP Family and ACL TOP Family 50 Series" | Tested across 3 lots per CLSI EP25-A. |
  | Real-time Shelf-life Stability | Device maintains stated performance throughout its claimed shelf-life. | "The study will continue to a point past final claim." (Ongoing assessment to support shelf-life). | Tested across 3 lots per CLSI EP25-A. |

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

• Precision:

  • Sample Size: 80 measurements per instrument per lot (n=80/instrument/lot) for PT (controls + 6 native patient samples) and Fibrinogen (controls + 6 fibrinogen sample pools at 3 levels). Tested across 3 lots and representative members of both ACL TOP Family and ACL TOP Family 50 Series.
  • Data Provenance: Not explicitly stated, but "native (unadulterated) patient samples" and "fibrinogen sample pools" suggest human biological samples. Typically, these studies are conducted in a controlled laboratory setting (Likely within the manufacturer's R&D facilities or a contract research organization). The document is submitted to the US FDA, implying relevance to the US market. The retrospective/prospective nature is generally prospective for these types of validation studies.

• Interference:

  • Sample Size: Two clinical sample levels each for PT (normal pooled plasma and a high INR clinical sample) and Fibrinogen (normal pooled plasma and a low fibrinogen sample). Specific "n" per concentration/sample type is not given, but refers to CLSI EP07, 3rd Ed and CLSI EP37, 1st Ed which define the study design.
  • Data Provenance: Not explicitly stated, but "clinical sample levels" implies human biological samples.

• Method Comparison:

  • Sample Size:
    • PT (INR): 160 samples (normal and abnormal) for both ACL TOP Family and ACL TOP Family 50 Series.
    • Fibrinogen (mg/dL): 135 samples for ACL TOP Family, 134 samples for ACL TOP Family 50 Series.
  • Data Provenance: Not explicitly stated, but "normal and abnormal samples" implies human biological samples. The study was "in-house."

• Open Vial and On-board Instrument Stability:

  • Sample Size: For PT, controls and four native (unadulterated) patient samples were tested in eight replicates at each time interval. For Fibrinogen, controls and six fibrinogen sample pools at three levels were tested in eight replicates at each time interval.
  • Data Provenance: Not explicitly stated, but "native (unadulterated) patient samples" and "fibrinogen sample pools" imply human biological samples.

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

This is not applicable for this type of IVD device. The ground truth for chemical assays like PT and Fibrinogen is established through precise measurement methods and reference materials, not through expert consensus of visual or diagnostic interpretations. The "truth" is the quantitative value derived from the reference method or calibrator.

4. Adjudication Method for the Test Set

Not applicable, as this is an IVD reagent and not an AI/ML-based diagnostic system requiring human interpretation or adjudication.

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, as this is an IVD reagent and not an AI/ML-based diagnostic system involving human interpretation.

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

Not applicable, as this is an IVD reagent. Its performance is inherent to the chemical reaction and the analytical instrument it is used with.

7. The Type of Ground Truth Used

The "ground truth" for this IVD is established by:

• Reference Methods/Materials: For PT and Fibrinogen, this would rely on internationally recognized standards and calibrators, and the values obtained from a validated reference method (or the predicate device in method comparison studies).
• Known Concentrations: For linearity and interference studies, samples are often spiked with known concentrations of analytes or interfering substances.
• Validated Predicate Device: In the method comparison study, the predicate device (HemosIL RecombiPlasTin 2G) serves as the comparator for verifying the new formulation's performance.

8. The Sample Size for the Training Set

Not applicable. This is an IVD reagent, not an AI/ML model that requires a "training set." The development of the reagent involves chemical formulation and optimization, not data-driven machine learning.

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

Not applicable, as there is no "training set" for an IVD reagent.

Ask a specific question about this device