(213 days)
The HEMOCHRON ® Response is intended for professional use for hemostasis management in a variety of clinical settings for the quantitative determination of an assortment of coagulation test assays including the following HEMOCHRON Whole Blood Coagulation Assays
Activated Clotting Time (ACT) -- All HEMOCHRON types Activated Partial Thromboplastin Time (APTT) - All HEMOCHRON types Prothrombin Time (PT) - All HEMOCHRON types Thrombin Time (TT) Heparin Neutralized Thrombin Time (HNTT) High Dose Thrombin Time (HiTT) Fibrinogen (FIB) Protamine Dose Assay (PDA) - All HEMOCHRON types Heparin Response Time (HRT) - All HEMOCHRON types Protamine Response Time (PRT) - All HEMOCHRON types
For In Vitro Diagnostic Use Only
The HEMOCIIRON® Response is an upgrade of the HEMOCHRON® Coagulation Instruments, HFMOCHRON® Model 8000 that was approved under 510(k) K930068 and the HEMOCHRON® Models 401 and 801. The HEMOCHRON® Response performs the same tests as the predicate HEMOCHRON@ Instruments. All test assays are previously 510(k) approved. The IIEMOCIIRON® Response employs the same mechanical clot detection system as the predicate HEMOCHRON® Instruments. Mechanical systems can be used to monitor clotling times in either whole blood or plasma samples.
The HEMOCHRON® employs a mechanical clot detection system. The principle of operation is based on the electrical field generated by a magnet contained within a glass test tube when the magnet is in close proximity to the detector located within the test well.
To perform a test, blood is added to the test tube and placed in the test well. The magnet freely rotates within the tube, in a non-clotted sample. The magnet position is detected by two solid-state Hall effect sensors. When a clot forms the magnet is caught within the clot and is shifted out of the detection area. The electrical change that occurs due to the magnet rotation triggers the timer to stop with an audible beep signaling clot formation to the user.
The HEMOCHRON® Response is a sollware / firmware and mechanical upgrade of the HEMOCHRON® Instruments designed to perform the same tests as the predicate instruments. The upgrade provides the end user with additional quality features not currently available in the predicate HEMOCHRON® Instruments.
The HEMOCHRON@ Response is a modification of the HEMOCHRON® Instruments with improved test well operation and reliability through the use of two Hall Effect solidstate detectors. This provides for full magnet position tracking within the test tube and eliminates the calibration drift of well parameters.
In addition a UPC-E bar code detector has been added to automatically read the affixed bar code label and identify the test assay, expiration date and lot number of the test assay, The instrument provides advanced patient and OC data tracking and streamlined computer interface capabilities which provide essential quality features for the end users.
{
"acceptance_criteria": {
"ACT": "r = 0.94 (clinical), r = 0.96 (in vitro heparin dose response)",
"APTT": "r = 0.99 (in vitro heparin dose response)",
"PT (citrate)": "r = 0.986 (freshly obtained blood specimens from patients receiving low doses of oral anticoagulant)",
"HITT": "r = 0.91 (in vitro heparin dose response)"
},
"reported_device_performance": {
"ACT": "y = 0.912x + 24.77 (clinical), y = 0.95x + 18.00 (in vitro heparin dose response)",
"APTT": "y = 1.03x - 4.51 (in vitro heparin dose response)",
"PT (citrate)": "y = 1.00x - 3.876 (freshly obtained blood specimens from patients receiving low doses of oral anticoagulant)",
"HITT": "y = 0.89x + 20.58 (in vitro heparin dose response)"
},
"study_details": {
"sample_size_test_set": {
"clinical_study": "42 patients (yielding 242 comparative ACT results)",
"ACT_in_vitro": "n = 66",
"APTT_in_vitro": "n = 41",
"PT_citrate": "n = 22",
"HITT_in_vitro": "n = 29"
},
"data_provenance": "Clinical data was collected using a split sample design. In vitro studies used normal donor blood.",
"number_of_experts_ground_truth": "Not specified, as the ground truth appears to be established through direct comparison to a predicate device using split samples and in vitro dose responses. The study design doesn't indicate the use of human experts for ground truth establishment in the traditional sense of consensus or subjective assessment.",
"qualifications_of_experts": "Not applicable given the nature of ground truth establishment.",
"adjudication_method": "None explicitly mentioned. The study relies on direct comparison of measurements between the new device and the predicate device.",
"multi_reader_multi_case_study": "No, this was not a multi-reader multi-case (MRMC) comparative effectiveness study. The study focuses on the performance comparison between two instruments.",
"standalone_performance": "Yes, the study describes the performance of the HEMOCHRON® Response instrument in comparison to predicate HEMOCHRON® instruments, which is a standalone assessment of the new algorithm/device functionality.",
"type_of_ground_truth": "The ground truth was established by comparing the results of the HEMOCHRON® Response to those obtained from the predicate HEMOCHRON® instruments (HEMOCHRON® Model 8000, 401, and 801). This is a form of comparative ground truth against an established device rather than independent expert consensus, pathology, or outcomes data.",
"sample_size_training_set": "Not explicitly stated. The document describes a "510(k) Summary" for a substantial equivalence determination, implying that the device is an upgrade to an existing product. It's likely that the device's algorithms were developed and refined using prior data, but specific training set sizes are not provided for this submission.",
"how_ground_truth_for_training_set_established": "Not explicitly stated. Given that the HEMOCHRON® Response is described as a software/firmware and mechanical upgrade of existing HEMOCHRON® instruments, it is probable that the algorithms were developed based on data from the predicate devices and their known performance characteristics. However, the document does not detail the specific process for establishing ground truth for any potential 'training set' specifically for this upgrade."
}
}
§ 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.