(178 days)
The CLINITEK Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Bayer reagent test strips for urinalysis (Multistix brand reagent strips), for testing in the clinical laboratory.
The automated analyzer is intended for the measurement of the following analytes: glucose, bilirubin, ketone, specific gravity, occult blood, pH, protein, urobilinogen, nitrite, leukocytes, albumin and creatinine.
The Clinitek Status® Urine Chemistry Analyzer is a portable, easy to use instrument which reads Baver urine reagent test strips (Multistix® brand). for testing in the clinical laboratory.
The Clinitek Status reports semi-quantitatively assays for 12 urine analytes [albumin (protein-low), bilirubin, blood (occult), creatinine, glucose, ketone, leukocyte, nitrite, pH, protein (protein-high), specific gravity, and urobilinogen). Reagent strip results are automatically displayed on the Clinitek Status in one (1) minute. A printed hardcopy can also be created either from the results screen or recalled from memory.
The analyzer features a display, internal printer, a serial computer interface, and either electrical outlet or battery operation. Communication between the operator and the analyzer is made through the display using the user interface touch screen on the front surface of the instrument.
The instrument performs a "self-test" and calibration each time the instrument is turned on. Each time a test is run the analyzer re-calibrates using a white plastic calibration bar located at the back of the test strip table.
Based on the provided text, here's an analysis of the acceptance criteria and the study information for the Clinitek Status Urinalysis Instrument:
Acceptance Criteria and Device Performance
The document does not explicitly state numerical acceptance criteria in a table format with corresponding reported device performance values. Instead, it relies on the concept of substantial equivalence to predicate devices. The core argument for acceptance is that:
- "The Clinitek Status instrument is similar in technological characteristics, device performance and intended use therefore is substantially equivalent to the predicate devices, the Clinitek 50 (# K960546), visual Multistix 10SG (# K905396), Clinitek Microalbumin (# K972706) and Multistix PRO 10LS (# K992257)."
This implies that the performance of the Clinitek Status is deemed acceptable if it performs comparably to these already approved predicate devices for the specified analytes. Without a direct table in the provided text, it's not possible to extract specific numerical acceptance thresholds (e.g., minimum sensitivity/specificity) or precise performance metrics for the Clinitek Status itself, as the submission focuses on equivalence.
Therefore, a table of acceptance criteria and reported device performance cannot be generated due to lack of explicit numerical data in the provided K031947 summary. The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence.
Study Information
The document does not contain details of any specific performance study that would fully address many of the requested points below. The submission focuses on demonstrating substantial equivalence primarily through technical characteristics and intended use alignment with predicate devices, rather than presenting a detailed, independent performance study with specific metrics.
Here's an attempt to answer the questions based only on the provided text, acknowledging significant gaps:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified. The document does not describe any specific test set or clinical study.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified. Since no test set or ground truth establishment process is described, this information is not available.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. No information on a test set or adjudication is provided.
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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:
- No MRMC study was mentioned. This device is an automated instrument for reading reagent strips, not an AI-assisted diagnostic tool for human readers. Therefore, this question is not applicable in the context of this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The Clinitek Status is an automated instrument that reads reagent strips; it inherently operates in a "standalone" fashion (algorithm/instrument only) for generating results. However, the document does not describe an independent "standalone performance study" with specific metrics beyond the general claim of substantial equivalence. The mechanism of its operation is standalone, but a dedicated study report is not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. Given the lack of a detailed performance study, the type of ground truth used (if any controlled testing was done beyond verification against predicate devices) is not mentioned. For urinalysis, typical ground truth might involve quantitative chemical analyses or expert visual interpretation, but the document doesn't confirm this.
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The sample size for the training set:
- Not applicable/Not specified. This device is not described as using machine learning or AI models that would require a "training set" in the conventional sense. It's an instrument based on optical detection and established chemistry principles.
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How the ground truth for the training set was established:
- Not applicable/Not specified. See point 7.
§ 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.