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CP3000 analyzer: The CP3000 is a fully automated, random-access in vitro blood coagulation analyzer intended for use by healthcare professionals in the clinical laboratory. The CP3000 analyzer is designed to process plasma samples photometrically using chromogenic assays.

Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination (AT) activity in human 3.2% citrated venous plasma. The reagent is intended for use on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use.

Coagpia Calibrator: The Coagpia Calibrator is intended for use as a calibration plasma for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel in clinical laboratories. For in vitro diagnostic use. - Coagpia AT Reagent

Coagpia Control Set: The Coagpia Control Set contains 2 levels of assaved plasma intended for the following Sekisui coagulation assay on Sekisui CP3000 analyzers by trained laboratory personnel. For in vitro diagnostic use. - Coagpia AT Reagent

Device Description

CP3000: The CP3000 is designed for easy-to-use, rapid in-vitro blood coagulation testing on citrated human plasma. The CP3000 system is capable of performing the chromogenic methodologic assay, giving the user the ability to perform analysis for both direct hemostasis measurements and calculated parameters. For these assay methodologies, the analyzers employs two photometric detection methods: light scattering and absorbance. The light scattering method uses light emitting diodes at a wavelength of 660 nm, and the absorbance method uses a halogen lamp with filters providing wavelengths at 405/570/730 nm.

Coagpia AT Reagent: Coagpia AT Reagent is intended for the quantitative determination of antithrombin (AT) activity in human plasma on the CP3000 analyzers. The reagent is supplied in a kit of 2 x 10 mL of Reagent 1 and 1 x 10mL of Reagent 2. Both reagents are liquid and do not require any preparation prior to use.

Coagpia Calibrator: The Coagpia Calibrator is supplied as 10 vials of lyophilized human plasma and is suitable for the calibration of the antithrombin activity assay using Coagpia AT Reagent on the CP3000 coagulation analyzers.

Coagpia Control Set: The Coagpia Control Set is supplied as10 vials of lyophilized human plasma; 5 vials of Level 1 Control and 5 vials of Level 2 Control and is suitable for use with the antithrombin activity assay using Coagpia AT Reagent on the CP3000 analyzers.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the CP3000 Coagulation analyzer, Coagpia AT Reagent, Coagpia Calibrator, and Coagpia Control Set, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (New Device)	Reported Device Performance (Coagpia AT Reagent on CP3000)
Precision (Coagpia AT Reagent)
Repeatability (Within-Run) CV	≤ 10%	0.7% - 2.9%
Between-Run CV	≤ 10%	0.8% - 5.1%
Between-Day CV	≤ 10%	0.0% - 0.4%
Between-Lot CV	≤ 10%	0.3% - 1.0%
Within-Laboratory CV	≤ 10%	1.1% - 5.8%
Between Instrument CV	≤ 15%	0.6% - 4.8%
Total CV	≤ 15%	1.3% - 7.7%
Analytical Sensitivity
Limit of Quantitation (LOQ)	Total error ≤ 15%	11%
Limit of Blank (LOB)	Not explicitly stated	3%
Limit of Detection (LOD)	Not explicitly stated	5%
Linearity	Allowable non linearity < 20%	14% - 140%
Clinical Reportable Range (CRR)	Design goal of 150%	14% - 179% (claim is 14% to 150%)
Analytical Specificity (Interference)	Insensitivity to listed substances	Insensitive to various substances (Hemoglobin, Triglyceride, Bilirubin, α2-Macroglobulin, α1-antitrypsin, Unfractionated heparin, Low Molecular Weighted heparin, Bivariludin, Dabigatran, Argatroban, Rivaroxaban)
Precision (Coagpia Calibrator)
Repeatability (Within-Run) CV	≤ 10%	0.8%
Between-Run CV	≤ 10%	1.5%
Between-Day CV	≤ 10%	0.0%
Between-Lot CV	≤ 10%	2.3%
Within-Laboratory CV	≤ 10%	2.8%
Between Instrument CV	≤ 15%	1.5%
Total CV	≤ 15%	3.2%
Precision (Coagpia Control Set)
Repeatability (Within-Run) CV	<10%	Level 1: 0.9%; Level 2: 2.5%
Between-Run CV	<10%	Level 1: 1.4%; Level 2: 4.4%
Between-Day CV	<10%	Level 1: 0.3%; Level 2: 1.9%
Between-Lot CV	<10%	Level 1: 1.1%; Level 2: 2.8%
Within-Laboratory CV	<10%	Level 1: 2.1%; Level 2: 6.0%
Between Instrument CV	<15%	Level 1: 1.5%; Level 2: 3.5%
Total CV	<15%	Level 1: 2.6%; Level 2: 6.9%
Method Comparison
Slope (vs. predicate)	0.90 to 1.10	1.012
Correlation Coefficient (r)	≥ 0.90	0.9909
Reproducibility (Coagpia AT Reagent)
Repeatability (Within-Run) %CV	≤ 10% (for all 6 levels)	0.8% to 3.8% (for all 6 levels)
Total Reproducibility %CV	≤ 15% (for all 6 levels)	1.1% to 7.5% (for all 6 levels)
Reproducibility (Coagpia Control Set & Calibrator)
Repeatability (Within-Run) %CV	≤ 10%	0.8% to 3.2%
Total Reproducibility %CV	≤ 15%	2.7% to 6.1%

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

Precision (Coagpia AT Reagent, Calibrator, Control Set):
- Sample Size: Six samples (for Reagent precision), three lots of Calibrator, three lots of Control Set. Each tested in duplicate, twice per day, for 20 non-consecutive days, on three CP3000 analyzers.
- Data Provenance: Not explicitly stated, but clinical laboratory settings are mentioned ("trained laboratory personnel in clinical laboratories"). Given it's a submission for US market through FDA, it likely includes data relevant to a US or internationally recognized clinical setting. It's prospective data collection given the structured study design (20 non-consecutive days).
Analytical Sensitivity (LOQ, LOB, LOD):
- Sample Size: Five natural plasmas (for LOQ, LOB, LOD), five analyte-free plasmas (for LOB, LOD). Measured in quadruplicate using three lots of Coagpia AT Reagent on two CP3000 analyzers. Measurement conducted for four days (total of 80 replicates per analyzer for LOQ).
- Data Provenance: Not explicitly stated. This is internal analytical validation data, likely from the manufacturer's lab. Prospective.
Linearity:
- Sample Size: High AT plasma diluted with AT deficient plasma to create a series of concentrations. Each sample measured in quadruplicate using three lots of Coagpia AT Reagent.
- Data Provenance: Not explicitly stated. Internal analytical validation data. Prospective.
Clinical Reportable Range (CRR):
- Sample Size: High AT plasma diluted with AT deficient plasma to create sample concentrations. Each sample measured in quadruplicate using three lots of Coagpia AT Reagent.
- Data Provenance: Not explicitly stated. Internal analytical validation data. Prospective.
Analytical Specificity (Interference):
- Sample Size: Not explicitly detailed, but involved testing sensitivity to various interfering substances.
- Data Provenance: Not explicitly stated. Internal analytical validation data. Prospective.
Method Comparison:
- Sample Size: 482 samples.
- Data Provenance: Left-over, prospectively collected, citrated plasma samples. Conducted at three (3) external sites. Country of origin not specified, but likely US given the FDA submission. Prospective.
Normal Reference Range:
- Sample Size: 179 samples.
- Data Provenance: Fresh citrated plasma samples collected from consented, apparently healthy adult volunteers. Conducted at three (3) external sites. Country of origin not specified, but likely US. Prospective.
Reproducibility (Coagpia AT Reagent, Calibrator, Control Set):
- Sample Size: Six levels (for Coagpia AT Reagent), Control Level 1, Control Level 2, and Calibrator (for Control Set and Calibrator). Each level had N=270 (implying 5 days x 2 runs/day x 3 replicates/run x 3 sites = 90 tests per site * 3 sites = 270 replicates).
- Data Provenance: Not explicitly stated, but conducted at three (3) external sites. Prospective.

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

There is no mention of "experts" or "ground truth" in the context of human interpretation or review of the test results for this
In-vitro Diagnostic (IVD) device. The ground truth for this type of device is typically established through:

Reference Methods: Comparison against established, legally marketed predicate devices, considered the standard for measuring AT activity.
Known Concentrations: Use of spiked samples, diluted samples, or reference materials with known concentrations of the analyte.
Clinical Studies: Determining normal reference ranges based on samples from healthy individuals.

The method comparison study used the predicate device (HemosIL Liquid Antithrombin on ACL TOP 700 System) as the reference for comparison, which implicitly serves as the "ground truth" for evaluating the new device's accuracy.

4. Adjudication Method for the Test Set

Not applicable. As described above, there's no mention of human adjudication of results in the context of this IVD device. The evaluations are based on quantitative measurements and statistical analysis against defined criteria and predicate device performance.

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 In-Vitro Diagnostic (IVD) device (coagulation analyzer and reagents), not an AI-assisted diagnostic imaging or interpretation system that would involve human "readers" or "AI assistance" in the typical sense of MRMC studies.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the studies presented are standalone performance studies of the device (CP3000 analyzer and Coagpia AT Reagent, Calibrator, Control Set). The device generates quantitative results (Antithrombin activity) automatically, without direct human intervention in the measurement process or interpretation beyond standard lab practices for running assays and reporting results. The device's performance is assessed based on its ability to accurately and precisely determine AT activity.

7. The Type of Ground Truth Used

The ground truth for the analytical and clinical studies varied:

Method Comparison: The predicate device (HemosIL Liquid Antithrombin on ACL TOP 700 System) served as the de facto "ground truth" or reference standard against which the new device's measurements were compared.
Precision, Analytical Sensitivity, Linearity, CRR, Analytical Specificity: Ground truth was established through known concentrations (e.g., highly concentrated plasma diluted with AT deficient plasma), calibrated reference standards, and defined acceptable ranges based on scientific principles and regulatory guidance (e.g., CLSI standards).
Normal Reference Range: Ground truth was derived from samples collected from "apparently healthy adult volunteers," establishing a statistically derived normal range for the population.

8. The Sample Size for the Training Set

No specific "training set" is mentioned in the context of machine learning. This is a traditional IVD device, not an AI/ML-based device that typically undergoes a distinct training phase with a dedicated dataset. The development and optimization of the analyzer and reagents would involve internal development and validation data, but this is not typically referred to as a "training set" in the context of regulatory submissions.

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

Not applicable, as there is no mention of a "training set" in the context of an AI/ML device.

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