(125 days)
The CLINITEK 50 Urine Chemistry Analyzer is for use with Bayer Reagent Strips for Urinalysis such as MULTISTIX 10-SG Reagent Strips for the determination of glucose, bilirubin, ketone, blood, protein, urobilinogen, nitrite and leukocytes in urine, urine pH, specific gravity and color. The tests provided on Bayer Reagent Strips and urine color are considered routine urinalysis.
The CLINITEK 50 Urine Chemistry Analyzer is a portable reflectance spectrophotometer that instrumentally measures the reflectance off a reacted Bayer Reagent Strip for Urinalysis. The CLINITEK 50 Urine Chemistry Analyzer displays and prints urinalysis results and can be connected to a laboratory computer for data management.
Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:
Disclaimer: The provided text is a 510(k) summary from 1996 for a medical device. The information is very high-level and lacks many details that would be expected in a modern, comprehensive study report. Therefore, some sections below will indicate where information is missing or inferred due to the limited scope of the summary.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state numerical acceptance criteria (e.g., sensitivity, specificity, accuracy percentages, or correlation coefficients with specific thresholds). Instead, the summary focuses on equivalence to predicate devices as the primary criterion.
| Acceptance Criterion (Inferred from Summary) | Reported Device Performance |
|---|---|
| Equivalence to Predicate Devices (CLINITEK 200+ and CLINITEK ATLAS Analyzers, and visual readout of MULTISTIX® 10-SG) | "The results of in-house and clinical evaluations of the CLINITEK 50 Urine Chemistry Analyzer demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use." |
| Operability by Intended User | "...the intended user can easily operate the instrument and obtain urinalysis results." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The summary only states "in-house and clinical settings" for studies, but no numbers of samples or patients are provided.
- Data Provenance: Not specified. The country of origin of the data is not mentioned. Given the submitter's address in Elkhart, IN, USA, it's likely the clinical settings were in the United States, but this is an inference. The studies included both "in-house" (likely laboratory-controlled) and "clinical" (real-world patient samples) components, suggesting a mix of retrospective and prospective data or a combination within larger prospective studies, but no definitive statement is made.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The summary mentions "clinical settings," implying healthcare professionals were involved, but their specific roles, number, or qualifications (e.g., medical technologists, pathologists, physicians) are not detailed. Given the nature of urinalysis interpretation, it's highly probable that trained laboratory professionals and/or clinicians were involved in establishing the ground truth from the predicate devices.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Since the primary criterion is "equivalence" to predicate devices, the "ground truth" for the CLINITEK 50's performance would have been established by the results from the predicate devices (CLINITEK 200+, CLINITEK ATLAS, or visual readout). It is not clear if there was any adjudication process to reconcile discrepancies between results from the predicate devices themselves or between the CLINITEK 50 and the predicate devices, beyond simply reporting the comparison outcomes.
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
- MRMC Study: No, an MRMC comparative effectiveness study, as typically understood (comparing human readers with and without AI assistance for interpretative tasks), was not explicitly mentioned or performed. This device is an automated urine chemistry analyzer, replacing manual visual interpretation or other automated systems. Its purpose is to provide objective measurements, not to assist human readers in interpreting complex images or clinical scenarios that would typically involve an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Yes, in a sense. The CLINITEK 50 Urine Chemistry Analyzer itself is a standalone automated system. The description states it "instrumentally measures the reflectance off a reacted Bayer Reagent Strip" and "displays and prints urinalysis results." The user manually places the strip, but the reading and interpretation of the strip's chemistry reaction are automated by the device. The studies were designed to show its performance as a standalone instrument compared to existing methods.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth was established by the predicate devices (MULTISTIX® 10-SG Reagent Strips for Urinalysis via visual readout, CLINITEK® 200+ Urine Chemistry Analyzer, and CLINITEK® ATLAS Urine Chemistry Analyzer). The studies aimed to show that the CLINITEK 50 produced equivalent results to these established methods, which are themselves considered reliable for urinalysis.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not specified. The summary does not provide any information about a training set. This is typical for devices of this era, especially those demonstrating equivalence rather than employing complex machine learning models that require distinct training and testing phases. The "in-house" studies might have involved initial development and refinement, but details are absent.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set: Not applicable/not specified. As no specific "training set" is mentioned in the context of a machine learning or AI algorithm, there is no information on how its ground truth would have been established. The development of the device's algorithms (e.g., for converting reflectance to meaningful units) would have likely relied on internal characterization and calibration using known concentrations and reference methods, but these are not described as a "training set" with separate ground truth establishment in the conventional sense.
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510(k) SAFETY AND EFFECTIVENESS SUMMARY
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| Prepared: | February 5, 1996 | K960546 | |
|---|---|---|---|
| Submitter: | Bayer Corporation, Business Group Diagnostics | ||
| Address: | 1884 Miles Avenue, P. O. Box 70Elkhart, IN 46515(219) 262-6929 | JUN 12 1996 | |
| Contact: | Rosanne M. Savol, R.A.C.Manager, Regulatory Affairs | ||
| Device: | Trade Name: | CLINITEK 50 Urine ChemistryAnalyzer | |
| Common Name: | Urine chemistry analyzer | ||
| Document Control Number: | K96 | ||
| ClassificationInformation: | Division of Clinical Laboratory DevicesPanel - Clinical Chemistry and ToxicologyClassification Code -- 75 KQO (automated urinalysis system) | ||
| Predicate Devices: | MULTISTIX® 10-SG Reagent Strips for Urinalysis(visual readout)CLINITEK® 200+ Urine Chemistry AnalyzerCLINITEK® ATLAS Urine Chemistry Analyzer | ||
| Device Description: | The CLINITEK 50 Urine Chemistry Analyzer is a portablereflectance spectrophotometer that instrumentally measures thereflectance off a reacted Bayer Reagent Strip for Urinalysis.The CLINITEK 50 Urine Chemistry Analyzer displays andprints urinalysis results and can be connected to a laboratorycomputer for data management. | ||
| Intended Use: | The CLINITEK 50 Urine Chemistry Analyzer is for use withBayer Reagent Strips for Urinalysis such as MULTISTIX 10-SGReagent Strips for the determination of glucose, bilirubin,ketone, blood, protein, urobilinogen, nitrite and leukocytes inurine, urine pH, specific gravity and color. The tests providedon Bayer Reagent Strips and urine color are considered routineurinalysis. |
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Bayer Corporation, Business Group Diagnostics CLINITEK® 50 Urine Chemistry Analyzer
Technological Characteristics:
- 1899
The CLINITEK 50 Urine Chemistry Analyzer is a reflectance spectrophotometer. It has similar technological characteristics to other CLINITEK® Urine Chemistry Analyzers such as the CLINITEK 200+ and CLINITEK ATLAS Analyzers. It is a small, portable instrument which makes it suitable for physician office laboratories. The user manually dips a Bayer Reagent Strip into a urine specimen and places it on the CLINITEK 50 Urine Chemistry Analyzer. The instrument times the reactions on the strip, measures the reflectance off the strip and converts the results to clinically meaningful units that correspond to the color chart on the bottle label of the strip. The urinalysis results are displayed on the instrument and can be printed or transferred to a laboratory computer.
Performance Studies:
Studies were conducted in-house and in clinical settings to demonstrate that the performance of the CLINITEK 50 Urine Chemistry Analyzer is equivalent to the predicate devices and that the intended user can easily operate the instrument and obtain urinalysis results.
Conclusion:
The results of in-house and clinical evaluations of the CLINITEK 50 Urine Chemistry Analyzer demonstrate that the device is equivalent in performance to the predicate devices and suitable for its intended use.
§ 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.