(165 days)
The Clinitek Status®+ Urine Chemistry Analyzer is a portable easy to use analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.
This analyzer is intended for the measurement of the following in urine: Albumin, Bilirubin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
These measurements are used to assist diagnosis in the following areas:
- Kidney Function
- Urinary tract infections
- Metabolic disorders (e.g. diabetes mellitus)
- Liver Function
- Pregnancy
Tests performed using the Clinitek Status®+ Analyzer are intended for in vitro diagnostic use only.
The Clinitek Status®+ Analyzer is intended for near patient (point-of-care) facilities and centralized laboratory locations.
The Clinitek Status®+ Analyzer, a device modification to the current Clinitek Status®, is a portable easy to use urine chemistry analyzer. It is designed to read only Siemens Reagent Strips for Urinalysis and Clinitest® hCG tests.
Identical to the Clinitek Status Analyzer, the Clinitek Status+ analyzer is intended for the measurement of the following in urine: Albumin, Blood (Occult), Creatinine, Glucose, Ketone, Leukocytes, Nitrite, pH, Protein-to-Creatinine Ratio, Albumin-to-Creatinine Ratio, Specific Gravity, Urobilinogen, and human Chorionic Gonadotropin (hCG).
The enhanced Analyzer identifies automatically all instrument-read Siemens strip types and adds a quality check to assess if the strip has been compromised by humidity exposure.
In addition, the enhanced Analyzer provides reporting flexibility by allowing users to select specific test parameters to report from on a given strip and provides enhanced security to allow for user/operator access restrictions.
When the connector is attached to the enhanced analyzer (Clinitek Status+), the model is referred to as Clinitek Status Connect System. Additional functionality is enabled including bar code data entry, quality control management, and connectivity to hospital network.
The optical system consists of six light emitting diodes, a light quide, a mirror, a lens and a detector. Light from the LEDs travels along the light quide and is reflected off the calibration bar, strip or cassette onto the mirror. It is then directed through an aperture on the lens, from where it is focused onto the detector. The light intensity detected is converted into electrical impulses, which are processed by the instrument's microprocessor and converted into clinically meaningful results.
Here's a breakdown of the acceptance criteria and study information for the Clinitek Status+ Analyzer and Clinitek Status Connect System, based on the provided 510(k) summary:
Clinitek Status+ Analyzer and Clinitek Status Connect System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the study as a comparison to a predicate device, focusing on "percent positive agreement (relative sensitivity) and percent negative agreement (relative specificity)." It states that the device "meet prescribed performance requirements." However, specific numerical acceptance criteria or numerical reported performance values for sensitivity and specificity are not provided in the summary. The document only offers a general statement of compliance.
| Parameter/Measurement Type | Acceptance Criteria (Not explicitly stated in document, only 'prescribed performance requirements') | Reported Device Performance |
|---|---|---|
| Urinalysis Strips (Multistix® 10SG): Percent Positive Agreement (Relative Sensitivity) | "prescribed performance requirements" | "meet prescribed performance requirements for percent positive agreement (relative sensitivity) relative to the predicate device (Clinitek Status)." |
| Urinalysis Strips (Multistix® 10SG): Percent Negative Agreement (Relative Specificity) | "prescribed performance requirements" | "meet prescribed performance requirements for percent negative agreement (relative specificity) relative to the predicate device (Clinitek Status)." |
| hCG levels | "prescribed limits" | "performance for both hCG levels tested meet prescribed limits." |
2. Sample Size and Data Provenance
- Sample Size for Test Set: 150 urine specimens
- Data Provenance: The document does not explicitly state the country of origin. It describes the study as "An internal study was conducted to demonstrate the performance." This suggests it was likely conducted in a controlled lab environment by Siemens Healthcare Diagnostics. The study is retrospective in the sense that it evaluates the modified device against an existing predicate device using collected specimens.
3. Number of Experts and Qualifications for Ground Truth
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The study compares the modified device's results to the predicate device's results, implying the predicate device's results serve as a form of "ground truth" or reference for performance. The initial ground truth establishment for the predicate device would have likely involved expert consensus, but this is not detailed for this specific study.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/not specified. The study directly compares the results of the modified device to the predicate device. It does not describe a process of expert adjudication for discrepancies, but rather a direct comparison of results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. This study focuses on the technical performance of the device itself (algorithm only) compared to a predicate device, not on human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance
- Standalone Performance: Yes, a standalone (algorithm only) performance assessment was done. The study specifically investigated "the impact of the proposed software enhancements on performance" and compared the device's readings to the predicate device's readings. This is a standalone evaluation of the device's ability to interpret the strips.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this study was the results obtained from the predicate device (Clinitek Status) when evaluating the same urine specimens. The study aims to show that the modified device's results are substantially equivalent to the predicate device.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The document does not provide details about a separate training set. This study seems to be a verification/validation study for a device with software enhancements, not the initial development of a new algorithm where training data would typically be mentioned.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable/not specified, as details about a separate training set or its ground truth establishment are not provided in the summary.
§ 862.1340 Urinary glucose (nonquantitative) test system.
(a)
Identification. A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.(b)
Classification. Class II.