(58 days)
The Alinity ci-series is intended for in vitro diagnostic use only.
The Alinity ci-series is a System comprised of inity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations including up to four Alinity i processing modules, up to four Alinity c processing modules, or a combination of up to four of Alinity i and Alinity c processing modules with a shared system control module to form a single workstation.
The Alinity c System is a fully automated, random/continuous access, clinical chemistry analyzer intended for the in vitro determination of analytes in body fluids.
The Alinity i System is a fully automated analyzer allowing random and continuous access, as well as priority and automated retest processing using chemiluminescent microparticle immunoassay (CMIA) technology is used to determine the presence of antigens, antibodies, and analytes in samples.
The Alinity c ICT (Integrated Chip Technology) is used for the quantitation of sodium, and chloride in human serum, plasma, or urine on the Alinity c analyzer.
Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension. Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.
Potassium measurements are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.
Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The Alinity c Glucose Reagent Kit is used for the quantitation of glucose in human serum, plasma, urine, or cerebrospinal fluid (CSF) on the Alinity c analyzer. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.
The Alinity i Total B-hCG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative and qualitative determination of beta-human chorionic gonadotropin (B-hCG) in human serum and plasma for the early detection of pregnancy on the Alinity i analyzer.
The Alinity ci-series is comprised of individual Alinity i or Alinity c analyzers/processing modules that may be arranged into individual or multimodule configurations which include either multiple Alinity i processing modules, multiple Alinity c processing modules, or a combination of up to four of both Alinity i and Alinity c processing modules with a shared system control module (SCM). The SCM includes the reagent and sample manager (RSM). The multimodule configurations do not have a separate device label or list number. In a multimodule configuration, each processing module retains its original unique identification label.
The document describes the non-clinical performance evaluation of the Alinity ci-series system, Alinity i Total ß-hCG Reagent Kit, Alinity c Glucose Reagent Kit, and Alinity c ICT Sample Diluent. The study focuses on demonstrating equivalent performance between the original single-module configurations and the new multi-module configurations.
Here's an breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating "equivalent performance" between the investigational multimodule system and the previously cleared single-module predicate devices. The reported performance metrics are precision (%CV) and method comparison parameters (slope and correlation coefficient). The document doesn't explicitly state numerical acceptance criteria thresholds, but rather implies that the observed results were within an acceptable range for "equivalent performance."
| Test Category | Analyte/Assay | Unit | Acceptance Criteria (Implicit: Equivalent Performance to Predicate) | Reported Device Performance (Investigational Method) |
|---|---|---|---|---|
| Within-Laboratory Precision (5-Day) | Alinity i Total ß-hCG | %CV | Expected to be comparable to, or within acceptable limits of, predicate device's precision. | 1.2% to 5.0% for samples from 5.25 to 12,850 mIU/mL |
| Alinity c Glucose (Serum) | %CV | Expected to be comparable to, or within acceptable limits of, predicate device's precision. | 0.4% to 1.8% for samples from 7 to 688 mg/dL | |
| Alinity c Glucose (Urine) | %CV | Expected to be comparable to, or within acceptable limits of, predicate device's precision. | 0.6% to 1.3% for samples from 36 to 737 mg/dL | |
| Alinity c ICT Sodium | %CV | Expected to be comparable to, or within acceptable limits of, predicate device's precision. | 0.3% to 0.5% for samples from 110 to 193 mmol/L | |
| Alinity c ICT Potassium | %CV | Expected to be comparable to, or within acceptable limits of, predicate device's precision. | 0.5% to 2.7% for samples from 1.9 to 9.0 mmol/L | |
| Alinity c ICT Chloride | %CV | Expected to be comparable to, or within acceptable limits of, predicate device's precision. | 0.4% to 1.2% for samples from 55 to 140 mmol/L | |
| Method Comparison | Alinity i Total ß-hCG | Slope | Expected to be close to 1.00 (indicating good agreement). | 0.98 |
| Alinity i Total ß-hCG | Correlation Coeff. | Expected to be close to 1.00 (indicating strong correlation). | 1.00 (for samples ranging from 2.74 to 14,998.60 mIU/mL) | |
| Alinity c Glucose (Serum) | Slope | Expected to be close to 1.00 (indicating good agreement). | 1.00 | |
| Alinity c Glucose (Serum) | Correlation Coeff. | Expected to be close to 1.00 (indicating strong correlation). | 1.00 (for samples ranging from 14 to 659 mg/dL) | |
| Alinity c Glucose (Urine) | Slope | Expected to be close to 1.00 (indicating good agreement). | 0.99 | |
| Alinity c Glucose (Urine) | Correlation Coeff. | Expected to be close to 1.00 (indicating strong correlation). | 1.00 (for samples ranging from 1 to 705 mg/dL) | |
| Alinity c ICT Sodium | Slope | Expected to be close to 1.00 (indicating good agreement). | 1.00 | |
| Alinity c ICT Sodium | Correlation Coeff. | Expected to be close to 1.00 (indicating strong correlation). | 1.00 (for samples ranging from 120 to 198 mmol/L) | |
| Alinity c ICT Potassium | Slope | Expected to be close to 1.00 (indicating good agreement). | 1.00 | |
| Alinity c ICT Potassium | Correlation Coeff. | Expected to be close to 1.00 (indicating strong correlation). | 1.00 (for samples ranging from 2.3 to 9.6 mmol/L) | |
| Alinity c ICT Chloride | Slope | Expected to be close to 1.00 (indicating good agreement). | 1.00 | |
| Alinity c ICT Chloride | Correlation Coeff. | Expected to be close to 1.00 (indicating strong correlation). | 1.00 (for samples ranging from 89 to 144 mmol/L) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the exact sample sizes (number of patient samples) for the precision and method comparison studies. It provides ranges of analyte concentrations, implying that multiple samples spanning these ranges were tested.
- Precision Studies: Samples across various concentration ranges (e.g., 5.25 to 12,850 mIU/mL for ß-hCG, 7 to 688 mg/dL for glucose serum, etc.) were used. The term "5-day precision" suggests a study design where samples are run over 5 days to assess within-laboratory variability.
- Method Comparison Studies: Samples across various concentration ranges were used (e.g., 2.74 to 14,998.60 mIU/mL for ß-hCG, 14 to 659 mg/dL for glucose serum, etc.).
Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that it's a pre-market submission to the FDA, the studies are typically prospective and conducted by the manufacturer, often at their own facilities or clinical study sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device. The ground truth for quantitative laboratory assays is typically established by reference methods or the performance of a cleared predicate device, not by expert consensus or physician review in the way it would be for imaging diagnostics. The "ground truth" here is the measurement obtained from the previously cleared single-module systems.
4. Adjudication method for the test set
Not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation (e.g., radiology reads) to resolve discrepancies among multiple expert reviewers. Here, the comparison is against quantitative measurements from a reference or predicate system.
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 submission is for an in vitro diagnostic (IVD) system that performs automated quantitative measurements, not an AI-assisted diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the automated Alinity ci-series system. The studies described (precision and method comparison) are essentially standalone performance evaluations comparing the new multimodule system to the existing single-module systems. There is no "human-in-the-loop" component in the sense of an operator making diagnostic interpretations based on the output. Operators load samples and reagents and manage the system, but the analytical measurement itself is automated.
7. The type of ground truth used
The ground truth used for comparison in these non-clinical studies is the performance of the predicate devices (Alinity i System for Alinity i Total ß-hCG, and Alinity c System for Alinity c Glucose and ICT assays) in their single-module configurations. The goal was to demonstrate "equivalent performance" of the new multimodule configurations to these already cleared systems. This is a form of comparative effectiveness against a legally marketed predicate device.
8. The sample size for the training set
Not applicable. This document describes the validation of a laboratory instrument system and reagent kits through non-clinical performance studies (precision, method comparison), not an AI/machine learning model that requires a distinct "training set." The methodology involves biochemical reactions and optical/potentiometric detection, which are established principles, not learned from a dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/ML model for this device.
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.