(63 days)
The CN-Series (CN-6000) is a fully automated coagulation analyzer intended for in vitro diagnostic use in the clinical laboratory. The instrument analyzes citrated plasma samples (3.2 % sodium citrate) collected from venous blood, using clotting, chromogenic and immunoassay methods.
The performance of this device has not been established in neonate and pediatric patient populations.
The CN-Series (CN-6000) coagulation analyzer is an automated blood coagulation instrument which can analyze samples using clotting, chromogenic and immunoassay methods. Analysis results are displayed on the IPU (Information Processing Unit) screen. They can be printed on external printers or transmitted to a host computer.
Sold separately from the instrument are the associated reagents, controls, calibrators, and consumable materials. The subject of this 510(k) notification is the analyzer together with the reagent applications which perform the coagulation tests:
- Prothrombin Time (PT) seconds and PT INR with Dade® Innovin®
- Activated Partial Thromboplastin Time (APTT) with Dade® Actin® FSL
- Fibrinogen (Fbg) with Dade® Thrombin Reagent
- Antithrombin (AT) with INNOVANCE® Antithrombin
- D-dimer with INNOVANCE® D-Dimer.
The analysis principles used on the instrument are reflected by the reagent application testing provided in this submission and are described in the table below. These reagents were selected to show the analytical technology of the instrument while also selecting commonly used applications in coagulation laboratories in the United States.
This document describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the Sysmex CN-6000 Automated Blood Coagulation Analyzer.
The provided text is a 510(k) clearance letter for an in vitro diagnostic device, specifically an automated blood coagulation analyzer. The information focuses on demonstrating substantial equivalence to a predicate device (Sysmex CS-5100 K150678) rather than providing detailed acceptance criteria and proof of exceeding them in the format typically seen for novel AI/ML devices. Therefore, the information has been extracted and interpreted as closely as possible to the requested structure, with explanations where the requested information is not explicitly present due to the nature of the document.
1. Table of Acceptance Criteria and Reported Device Performance
For an in vitro diagnostic device like the CN-6000, acceptance criteria are generally defined as meeting performance specifications comparable to the predicate device and within clinically acceptable ranges. The "acceptance criteria" for each study are generally defined as the results meeting these pre-established standards. The reported device performance is presented as the outcomes of these studies.
| Study Type | Acceptance Criteria (Implicit) | Reported Device Performance (CN-6000) |
|---|---|---|
| Method Comparison (Against Predicate CS-5100) | Results comparable to predicate device with high correlation (r-value close to 1.0) and minimal bias (slope close to 1.0, intercept close to 0). | PT (seconds): y = 1.010x – 0.100, r = 0.999 (n=847) |
| PT (INR): y = 1.010x – 0.010, r = 0.999 (n=813) | ||
| APTT: y = 0.993x + 0.088, r = 0.996 (n=638) | ||
| Fibrinogen: y = 1.062x – 4.092, r = 0.993 (n=456) | ||
| Antithrombin: y = 0.984x – 0.998, r = 0.995 (n=450) | ||
| D-dimer: y = 0.959x + 0.007, r = 0.997 (n=395) | ||
| All results from each assay met the pre-established acceptance criteria. | ||
| Precision | Within-site precision (SD/CV) within acceptable clinical laboratory limits for each analyte. | CVs generally low (e.g., PT seconds: 0.2-1.8%, PT INR: 0.4-2.2%, APTT: 0.3-2.6%, Fibrinogen: 1.0-6.2%, Antithrombin: 0.9-5.2%, D-Dimer: 1.7-5.8%), meeting pre-established criteria. |
| Linearity & Measuring Range | Measured linear range should encompass or be equivalent to the Analytical Measurement Interval (AMI). | Measured ranges effectively supported the claimed AMI for Fibrinogen (38.4-900.2 mg/dL vs. 50-860 mg/dL), Antithrombin (7.56-130.42% vs. 9.0-128.0%), and D-dimer (0.180-35.836 mg/L FEU vs. 0.19-35.20 mg/L FEU). All reagents met the predetermined acceptance criteria. |
| Interference Studies | No significant interference from hemoglobin, bilirubin, triglycerides, and HES up to specified concentrations. | All pre-established criteria were met, demonstrating substantial equivalent optical performance. |
| Reagent Carryover | No significant carryover effects from one application to another. | All results met the specified criteria. |
| Sample Carryover | Negligible carryover contamination between samples. | All results met the specified criteria. |
| Limit of Blank/Detection/Quantitation (LoB/LoD/LoQ) | Measured limits within acceptable performance for each assay. | Fibrinogen LoQ: 36.1 mg/dL. Antithrombin LoB: 2.21%, LoD: 2.95%, LoQ: 8.31%. D-Dimer LoB: 0.085 mg/L FEU, LoD: 0.101 mg/L FEU, LoQ: 0.182 mg/L FEU. |
| Factor Sensitivity (PT, APTT) | Reagent sensitivity to factors V, VII, VIII, IX within acceptable ranges. | Factor V: 40.8% - 44.5%. Factor VII: 45.8% - 48.3%. Factor VIII: 40.2% - 42.8%. Factor IX: 33.2%. |
| Heparin Sensitivity (APTT) | High correlation between CN-6000 and CS-5100 results for heparinized samples. | Lot 1: n = 56, y = 1.000x - 0.200, r = 0.9993. Lot 2: n = 56, y = 0.981x - 0.313, r = 0.9995. |
| Lupus Anticoagulant (LA) Sensitivity | Acceptable performance with LA positive samples. | Results for the study met the specified criteria. |
| Stability (Reagents & QC) | Manufacturer's claim for onboard stability met for reagents and QC materials. | Manufacturer's claim for onboard stability for all reagents and QC materials was met. |
| High Dose Hook Effect | Appropriate instrument flagging ("antigen excess") and no erroneously low results up to 500 mg/L FEU. | Acceptance criterion was met. |
| Matrix Comparison (Auto-Dilution vs Manual, Uncapped vs Capped, Frozen vs Fresh, Micro vs Normal Mode) | Equivalence of results across different sample handling/processing methods. | Pre-defined acceptance criteria were met for all matrix comparison studies. |
| Reference Range | Established adult reference intervals. | PT (seconds): 9.9 – 12.3. PT (INR): 0.93 – 1.16. APTT: 23.8 – 32.0. Fibrinogen: 192 – 440 mg/dL. Antithrombin: 83.7 – 121.6%. D-Dimer: |
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.