(20 days)
The Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative determination of the following urine analytes: specific gravity, pH, leukocytes, nitrite, glucose, ketones, urobilinogen, bilirubin and blood.
According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.2900, 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.
The Chemstrip 101 Urine Analyzer is a reflectance photometer intended for in-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips for the following analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.
The modifications which have been incorporated into the Chemstrip 101 Urine Analyzer are:
1.) an additional calibration fail-safe mechanism;
2.) an automated test strip holder;
3.) a rotating reader head, and
4.) increased results memory capacity
This document is a 510(k) summary for the Chemstrip 101 Urine Analyzer by Boehringer Mannheim Corporation (doing business as Roche Diagnostics). This device is an automated urinalysis system intended for in-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips.
1. Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy percentages, precision ranges) for the Chemstrip 101 Urine Analyzer. Instead, the basis for substantial equivalence is primarily focused on similarity to a predicate device (Chemstrip Mini UA Urine Analyzer) and the safety/effectiveness of modifications.
The document highlights the following performance aspects through comparison to the predicate:
| Acceptance Criteria/Performance Aspect | Chemstrip 101 Urine Analyzer Reported Performance | Predicate Device (Chemstrip Mini UA Urine Analyzer) Performance | Comments |
|---|---|---|---|
| Intended Use | In-vitro semi-quantitative determination of urine analytes | Same | Identical intended use, implying similar performance expectations for detecting analytes. |
| Scientific Technology | Reflectance Photometer | Same | Uses the same core principle for reading test strips. |
| Urine Test Strips | For use with Chemstrip 10 UA test strips | Same | Compatible with the same test strips, suggesting consistency in chemical reactions. |
| Test Parameters | Specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood. | Same | Measures the same panel of analytes, implying identical analytical capabilities. |
| Calibration Fail-Safe | Enhanced fail-safe mechanism: Prevents tests after weekly calibration limit until calibration is performed. | "Repeat Calibration" message displayed, but no lock-out mechanism. | Improved safety feature; prevents use of un-calibrated device. |
| Automated Test Strip Tray | Motor-driven, automatically positions strip for measurement. | Manual test strip tray. | Automation for user convenience and potentially improved consistency in strip placement. |
| Reader Head | One rotating reader head. | 11 fixed-position LEDs. | A design change optimizing the reading process due to automated strip movement while maintaining the same light source and technology. |
| Results Memory Capacity | Stores up to 100 sample results, with reprint option. | Did not have memory capability. | Enhanced functionality for data management. |
Summary of Acceptance Criteria and Performance: The acceptance criteria for the Chemstrip 101 appear to be based on demonstrating substantial equivalence to the predicate device in terms of intended use, scientific technology, and tested parameters, with additional safety and usability enhancements that do not negatively impact fundamental performance. The study described focuses on comparing the new device's features and functionalities against a previously cleared device. There are no explicit quantitative performance criteria (e.g., accuracy, precision studies) provided in this summary. The implicit acceptance is that the modifications do not degrade the analytical performance compared to the predicate and that the added features are effective and safe.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The document describes the device and its modifications, and then asserts substantial equivalence to a predicate. It discusses the functional differences and improvements, but not a clinical or performance study with a distinct test dataset.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the 510(k) summary. Since no clinical or performance study with a defined test set and ground truth is described, there's no mention of experts or their qualifications for establishing ground truth.
4. Adjudication Method
This information is not provided in the 510(k) summary. As no clinical or performance study involving human interpretation or uncertain cases is detailed, an adjudication method is not applicable in this context.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A Multi Reader Multi Case (MRMC) comparative effectiveness study was not described or done based on the provided summary. This type of study would typically involve human readers interpreting results with and without AI assistance to measure effect size, which is not relevant for an automated urinalysis system.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study focused on the algorithm only (without human-in-the-loop performance) was not explicitly described in the provided summary. The document focuses on demonstrating that the device, with its automated features, functions comparably to the predicate device in terms of its ability to read test strips. Detailed analytical performance data (e.g., accuracy, precision against a reference method) are not included in this summary, which would typically be part of a standalone study for an analytical measurement device.
7. Type of Ground Truth Used
The provided 510(k) summary does not specify the type of ground truth used because it does not detail a performance study that required establishing ground truth for evaluating the device's analytical accuracy. The focus is on the device's functional equivalence and safety of modifications compared to a predicate. For an in-vitro diagnostic, analytical performance studies would typically compare device results to a recognized reference method or instrument to establish ground truth for each analyte.
8. Sample Size for the Training Set
The provided 510(k) summary does not include information about a training set or its sample size. The device is a reflectance photometer that reads pre-impregnated test strips, not a machine learning or AI-based system that typically requires a "training set" in the conventional sense. The device is calibrated and designed based on established chemical reactions and optical principles.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" in the context of the device's development as presented in the 510(k) summary, information on how its ground truth was established is not applicable and not provided.
§ 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.