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Lumipulse G CA15-3 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of CA 15-3 in human serum or plasma (sodium heparin, lithium heparin, or dipotassium EDTA) on the LUMPULSE G System.

The assay is to be used as an aid in the management of patients previously diagnosed with stage II and III breast cancer. Serial testing for patient CA15-3 assay values should be used in conjunction with other clinical methods used for monitoring breast cancer.

WARNING: The concentration of CA 15-3 in a given specimen, as determined by assays from different manufacturers, can vary due to differences in assay methods and reagent specificity. The results reported by the laboratory to the physician must include the identity of the assay for CA 15-3 used. Values obtained with different assay methods cannot be used interchangeably. If, in the course of monitoring a patient, the assay method used of CA 15-3 is changed, the laboratory must perform additional serial testing to confirm baseline values. Prior to changing assays, the laboratory MUST confirm baseline values for patients being serially monitored. Lumipulse G CA 15-3 should not be used for cancer screening or diagnosis.

Device Description

Lumipulse G CA15-3 is an assay system, including a set of immunoassay reagents, for the quantitative measurement of CA 15-3 in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System.

Lumipulse G CA15-3 Immunoreaction Cartridges: REF 235102 The Lumipulse G CA15-3 Immunoreaction Cartridges consists of 3 x 14 tests. Each kit contains the following:

1.) Antibody-Coated Particle Solution (Liquid when used, 250 µL/Immunoreaction Cartridge) Contains 150 µg/mL anti-CA 15-3 monoclonal antibody (mouse)-coated particles, protein stabilizers (bovine and mouse) and chemical stabilizers in 0.15 M sodium chloride/Tris buffer. This solution contains gelatin and turns into gel at 15°C or lower. Preservative: sodium azide.

2.) Enzyme-Labeled Antibody Solution (Liquid, 350 µL/Immunoreaction Cartridge) Contains 0.2 µg/mL alkaline phosphatase (ALP: calf)-labeled anti-CA 15-3 monoclonal antibody (mouse), protein stabilizers (bovine and calf) and chemical stabilizers in 0.1 M sodium chloride/MES buffer. Preservative: sodium azide.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document, restructured to answer your specific questions:

1. A table of acceptance criteria and the reported device performance

The document primarily focuses on validating the Lumipulse G CA15-3 assay as "substantially equivalent" to a predicate device (ARCHITECT CA 15-3) and demonstrating its analytical and clinical performance. The acceptance criteria are largely implicit, based on meeting established guidelines (CLSI) and demonstrating satisfactory performance within defined ranges or against a predicate.

Acceptance Criteria Category	Specific Criteria/Target	Reported Device Performance (Lumipulse G CA15-3)
Precision/Reproducibility	Total precision (CV) ≤ 10% for controls and panels	20-day Precision: ≤ 3.3% (Range: 2.4% to 3.3%)
	Lot-to-Lot Total Precision (CV) ≤ 10%	≤ 3.3% (Range: 2.2% to 3.7%)
	Between-Lot Precision (CV)	≤ 4.8%
	Site-to-Site Total Precision (CV) ≤ 10%	≤ 6.7% (Range: 2.9% to 6.7%)
	Between-Site Precision (CV)	≤ 4.9%
Linearity/Reportable Range	Linear range established	1.7 U/mL to 434.8 U/mL
	High dose effect	No high dose effect observed up to 9,000 U/mL
Detection Limit	LoB, LoD, LoQ established	LoB: 0.022 U/mL, LoD: 0.053 U/mL, LoQ: 0.138 U/mL
	LoQ standard deviation ≤ 15% of mean	Yes, met for LoQ of 0.138 U/mL
Interfering Substances	Average interference ≤ ±10%	Demonstrated ≤ ±10% interference for all tested endogenous and therapeutic compounds
Method Comparison (vs. Predicate)	Correlation coefficient (r) with predicate	0.8537
	Slope (95% CI) with a predicate that includes 1	1.0512 (0.9674 to 1.1350)
	Intercept (95% CI) with a predicate that includes 0	0.4628 (-0.3189 to 1.2445)
Matrix Comparison	Slope for each tube type (vs. control) 95% CI between 0.9 and 1.1	Met for all tested tube types (SST, K2EDTA, Lithium Heparin, Sodium Heparin)
	Correlation coefficients (r) ≥ 0.9	Met for all tested tube types
Clinical Performance (Disease Monitoring)	Demonstrate ability to aid in monitoring disease status	Serial testing for CA15-3 assay values should be used in conjunction with other clinical methods. A ≥21% change indicates an approximate 25% likelihood of progression. A

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