FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The intended use of the Sysmex® CA-500 is as a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.

The instrument uses citrated human plasma to perform the following parameters and calculated parameters:

Clotting Analysis Parameters

Prothrombin Time (PT) ●
Activated Partial Thromboplastin Time (APTT) .
Fibrinogen (Clauss) .

Chromogenic Analysis Parameters

Antithrombin III ●
Protein C t

Calculated Parameters

PT Ratio .
PT INR ●
Batroxobin .
Protein C ●
Heparin .
Derived Fibrinogen .

Device Description

The Sysmex® CA-500 is intended for use as an automated citrated human plasma coagulation analyzer.

AI/ML Overview

{
  "acceptance_criteria_and_study": {
    "1._table_of_acceptance_criteria_and_reported_device_performance": {
      "Method Comparison Studies": {
        "Predicate Device": "Behring Coagulation Timer (BCT) or Behring Fibrintimer A (BFA)",
        "Acceptance Criteria (Implicit)": "Coefficient of Correlation (r) > 0.95 for method comparison to predicate device",
        "Reported Device Performance": {
          "Batroxobin (vs. BCT)": "r = 0.984",
          "Protein C, Chromogenic (vs. BCT)": "r = 0.963",
          "Heparin, Chromogenic (vs. BCT)": "r = 0.977",
          "Protein C, Coagulometric (vs. BFA)": "r = 0.974"
        }
      },
      "Precision Studies": {
        "Acceptance Criteria (Implicit)": "Low %CV (Coefficient of Variation) for within-run, between-run, and total precision.",
        "Reported Device Performance": {
          "Batroxobin Time (CPN)": "Within-Run %CV = 1.0, Between-Run %CV = 1.2, Total %CV = 1.5",
          "Batroxobin Time (Pool Plasma 2)": "Within-Run %CV = 1.9, Between-Run %CV = 0.7, Total %CV = 1.9",
          "Protein C Coagulometric (CPN)": "Within-Run %CV = 4.8, Between-Run %CV = 3.6, Total %CV = 5.8",
          "Protein C Coagulometric (CPP)": "Within-Run %CV = 9.0, Between-Run %CV = 6.2, Total %CV = 10.4",
          "Protein C Chromogenic (CPN)": "Within-Run %CV = 1.6, Between-Run %CV = 1.0, Total %CV = 1.8",
          "Protein C Chromogenic (CPP)": "Within-Run %CV = 3.6, Between-Run %CV = 1.4, Total %CV = 3.6",
          "Heparin (Ci-Trol Hep Hi)": "Within-Run %CV = 4.0, Between-Run %CV = 5.2, Total %CV = 6.4",
          "Heparin (Ci-Trol Hep Lo)": "Within-Run %CV = 5.6, Between-Run %CV = 4.7, Total %CV = 7.1"
        }
      }
    },
    "2._sample_size_used_for_the_test_set_and_the_data_provenance": {
      "Method Comparison Studies": {
        "Batroxobin": "183 samples",
        "Protein C, Chromogenic": "114 samples",
        "Heparin, Chromogenic": "53 samples",
        "Protein C, Coagulometric": "Not explicitly stated for BFA comparison, but implied to be similar numbers for other tests (e.g., 114 range for Protein C tests with BCT)",
        "Data Provenance": "Specimens were evaluated from apparently healthy individuals and from patients with different pathological conditions which are expected to affect the results for a particular assay. Country of origin not specified, but likely within Dade Behring's operational regions (e.g., USA, Europe). Retrospective or prospective not specified, but typically prospective for method comparison studies."
      },
      "Precision Studies": {
        "Batroxobin Time (CPN/Pool Plasma 2)": "40 samples per level",
        "Protein C Coagulometric (CPN/CPP)": "40 samples per level",
        "Protein C Chromogenic (CPN/CPP)": "40 samples per level",
        "Heparin (Ci-Trol Hep Hi/Lo)": "32 samples per level",
        "Data Provenance": "Control materials (CPN, CPP, Ci-Trol Hep Hi/Lo) and pooled plasma. Country of origin not specified. Prospective testing."
      }
    },
    "3._number_of_experts_used_to_establish_the_ground_truth_for_the_test_set_and_the_qualifications_of_those_experts": "Not applicable. This device is an automated coagulation analyzer, and its performance is evaluated against established laboratory methods (predicate devices) and internal quality control samples, not against expert human interpretation of clinical data or images.",
    "4._adjudication_method_for_the_test_set": "Not applicable. Ground truth for performance studies of automated laboratory analyzers is typically established by the results from a legally marketed predicate device or by standard reference materials, not through expert 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. This is an automated laboratory analyzer, not an AI-assisted diagnostic imaging or interpretation device that would involve human readers.",
    "6._if_a_standalone_(i.e._algorithm_only_without_human-in-the-loop_performance)_was_done": "Yes. The studies presented (method comparison and precision) evaluate the standalone performance of the Sysmex® Automated Coagulation Analyzer CA-500 against predicate devices and internal controls. There is no human-in-the-loop component for the analytical performance itself.",
    "7._the_type_of_ground_truth_used": "The ground truth for the test set (method comparison) was established by the measurements obtained from legally marketed predicate devices (Behring Coagulation Timer (BCT) and Behring Fibrintimer A (BFA)). For precision studies, it was based on the expected values of control materials and pooled plasmas.",
    "8._the_sample_size_for_the_training_set": "Not applicable. This is an automated laboratory analyzer, not a machine learning or AI-based device that typically requires a 'training set'. Its operational parameters are likely calibrated during manufacturing and validated through performance testing.",
    "9._how_the_ground_truth_for_the_training_set_was_established": "Not applicable for the same reasons as above. The device's internal algorithms are based on established coagulation measurement principles, not learned from a training dataset."
  }
}

Summary

Regulation Number and Section

§ 864.5400 Coagulation instrument.

(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.