(88 days)
The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed system, the HemoCue Albumin 201 analyzer. The system is designed to be used for the quantitative determination of low levels of albumin in urine at the point-of-care for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes. For professional use only.
The HemoCue Albumin 201 analyzing system consists of an analyzer and specially designed microcuvettes. The microcuvette contains reagents deposited on its inner walls. The plastic microcuvette is filled with a urine sample and inserted into the analyzer. Within the analyzer, the contents of the cuvette are mixed through vibration. The immunochemical reaction is completed and the turbidity is measured. The albumin concentration is proportional to the turbidity. When the end point is reached, the result is displayed in mg/L.
The HemoCue Albumin 201 analyzing system is intended for the quantitative, rapid, turbidimetric immunoassay of albumin in human urine. It is designed for screening, diagnosing, monitoring, and supplementing clinical evidence in the treatment of microalbuminuria.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific numerical acceptance criteria for the device's performance (e.g., a specific correlation coefficient, accuracy range, or precision metric). It broadly states that studies were conducted "to demonstrate the performance of the HemoCue Albumin 201 System and that the intended user can easily operate the system and obtain urinalysis results as the predicate device."
Therefore, the table below will reflect the stated performance goal (equivalence to the predicate device) rather than specific numerical criteria.
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Obtain urinalysis results comparable to the predicate device (Clinitek 50 Urine Chemistry Analyzer). | Studies demonstrated that the HemoCue Albumin 201 system performs as the predicate device. |
| Intended user can easily operate the system. | Studies demonstrated that the intended user can easily operate the system. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions that "Studies were conducted in-house and in clinical settings."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The document does not provide any information regarding the number of experts used to establish ground truth or their qualifications. The system is an automated urinalysis system, which typically relies on laboratory methods or comparison to a reference standard rather than expert interpretation of images or other subjective data.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method for the test set. Given it's an automated quantitative immunoassay, an adjudication method in the traditional sense (e.g., for diagnostic imaging interpretation) is unlikely to be applicable. Performance is usually assessed by comparison to a reference method or predicate device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The device is an automated system; therefore, an MRMC study comparing human readers with and without AI assistance is not relevant in this context.
6. Standalone Performance Study
Yes, a standalone performance study was implicitly done. The "Assessment of Performance" section describes studies conducted to "demonstrate the performance of the HemoCue Albumin 201 System." This indicates testing of the algorithm/device itself to show it produces results comparable to the predicate device.
7. Type of Ground Truth Used
Based on the information, the ground truth was established by comparison to a predicate device, the Clinitek 50 Urine Chemistry Analyzer. The statement "obtain urinalysis results as the predicate device" strongly suggests that the Clinitek 50 served as the reference standard for evaluating the HemoCue Albumin 201's performance.
8. Sample Size for the Training Set
The document does not mention the sample size for the training set. Modern immunoassay devices, particularly those relying on established turbidimetric principles, often leverage extensive historical data and chemical principles during development and calibration rather than a distinct "training set" in the machine learning sense. The device is "factory calibrated."
9. How the Ground Truth for the Training Set Was Established
The document does not explicitly describe how ground truth for a training set was established. It states the system is "factory calibrated," which implies internal calibration procedures typically using known concentration standards, but details are not provided. The development process likely involved using reference methods (like those used for the predicate device) to establish the accuracy of the system's measurements against known albumin concentrations.
§ 862.2900 Automated urinalysis system.
(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.