(67 days)
The intended use of the Sysmex® CA-6000 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)
- Thrombin Time
Chromogenic Analysis Parameters
- Antithrombin III
- Plasminogen
- Extrinsic Factors (II, V, VII, X)
- Intrinsic Factors (VIII, IX, XI, XII)
- Batroxobin
- Protein C
- Protein C
- Heparin
Calculated Parameters
- PT Ratio
- PT INR
- Derived Fibrinogen
The Sysmex® CA-6000 is intended for use as an automated blood plasma coagulation analyzer. It is a fully automated, computerized blood plasma coagulation analyzer for in vitro diagnostic use in clinical laboratories.
1. Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Coefficient of Correlation (r)) | Reported Performance (Coefficient of Correlation (r)) |
|---|---|---|
| Batroxobin | Not explicitly stated, implied by predicate equivalence | 0.949 |
| Protein C, Chromogenic | Not explicitly stated, implied by predicate equivalence | 0.956 |
| Heparin, Chromogenic | Not explicitly stated, implied by predicate equivalence | 0.995 |
| Protein C, Coagulometric | Not explicitly stated, implied by predicate equivalence | 0.950 |
Note: The document states the performance claims of the proposed device are "similar to the predicate device" based on correlation studies. There are no explicit numeric acceptance criteria provided in the given text for the coefficient of correlation, but the high values reported (all above 0.949) indicate a strong correlation, satisfying the broad "similar" claim.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Sample Sizes:
- Batroxobin: 173 samples
- Protein C, Chromogenic: 113 samples
- Heparin, Chromogenic: 59 samples
- Protein C, Coagulometric: 88 samples
- Data Provenance: The studies were "in-house correlation studies." Specimens were evaluated from "apparently healthy individuals and from patients with different pathological conditions." The country of origin is not explicitly stated, but the manufacturing site is Kobe, Japan, and the importer is in Long Grove, IL, USA, and the distributor is in Newark, DE, USA. The study design is prospective in the sense that specimens were "evaluated" for the purpose of the comparison.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable. This study is a method comparison study between a new device and a predicate device, not a diagnostic accuracy study requiring expert adjudication for ground truth. The "ground truth" for each sample is the measurement produced by the predicate device (BCT or BFA).
4. Adjudication Method for the Test Set:
Not applicable. See point 3. This was a direct comparison between the new device's readings and the predicate device's readings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This study focuses on the instrumental performance of an automated coagulation analyzer compared to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the context of comparing the new device (Sysmex CA-6000) against predicate devices (BCT and BFA). The provided data represents the performance of the Sysmex CA-6000 in measuring various coagulation parameters, showing its direct correlation with established methods.
7. Type of Ground Truth Used:
The "ground truth" for the method comparison studies was the measurements obtained from the established predicate devices: the Dade Behring Coagulation Timer (BCT) and the Behring Fibrintimer A (BFA). This is a form of comparative measurement against a recognized standard.
8. Sample Size for the Training Set:
Not applicable. This device is an automated coagulation analyzer, not an AI/machine learning algorithm requiring a separate "training set" in the conventional sense for model development. The study described is a validation of the instrument's measurement performance against predicate devices.
9. How Ground Truth for the Training Set Was Established:
Not applicable. See point 8.
§ 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.