Search Results

ARJ Medical URITEST 50 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARI Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.

ARI Medical URITEST 50 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

ARJ Medical Uritest 500 urine analyzer is a semi-automated, bench top instrument which is intended for prescription, in vitro diagnostic use with the URITEST 10 Urinalysis Reagent Strips manufactured by ARJ Medical, Inc. This system performs qualitative detection of Nitrites and semi-quantitative detection of Urobilinogen, Bilirubin, Ketone, Blood, Protein, Leukocytes, Glucose, Specific gravity and pH. The instrument uses the accompanying check strip for daily calibration.

ARJ Medical URITEST 500 Urinalysis Analyzer is for use in professional near patient (point-of-care) facilities and centralized laboratory. The analyzer is intended for use in screening at-risk patients to assist diagnosis in the following areas: Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

ARJ Medical Uritest 50 and Uritest 500 urine analyzer is a kind of semi-automatic photoelectronic colorimeter that can be used together with the Uritest 10 Urine Reagent Strips manufactured by ARJ Medical, Inc. Adopting the advanced "super-high luminosity cold light source reflection determination" technology, the "high luminosity cold light source" has two main advantages. (1) the usable life of a cold light is longer than the normal light source (2) the temperature of the normal light source will increase during testing, affecting the test result vs the temperature of the cold light source is constant not potentially affecting the result. It can finish the tests on 10 kinds of biochemical components in urine within 30 seconds, and it also can revise the affects toward the test result which is caused by ambient temperature, ambient light, acid-base scale and abnormally colored sample. The Uritest 50 and Uritest 500 urine analyzers are in vitro-diagnostic devices (IVDD).

Here's an analysis of the acceptance criteria and study details for the URITEST 50 and URITEST 500 Urine Analyzers, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria (e.g., minimum sensitivity, specificity, or agreement percentages). Instead, the criterion for device performance is implicitly defined as providing "test results consistent with laboratory methods and performance comparable to that of the Bayer Clinitek 50 Urine Analyzer and the Bayer Clinitek 500."

Therefore, the table below reflects this comparative performance and the conclusion drawn from the study.

2. Sample Size Used for the Test Set and Data Provenance

• Total Sample Size (Test Set): 901 urine samples
  • 520 natural negative samples
  • 381 positive natural urine samples
• Distribution by Site:
  • No.1 Clinical Hospital of Jilin University: 135 Negative, 110 Positive (245 total)
  • China-Japan Friendship Hospital of Jilin University: 180 Negative, 140 Positive (320 total)
  • The People's Hospital of Jilin Province: 205 Negative, 131 Positive (336 total)
• Data Provenance: The data was collected from three hospital laboratory settings in China (as indicated by the names of the hospitals: "No.1 Clinical Hospital of Jilin University," "China-Japan Friendship Hospital of Jilin University," and "The People's Hospital of Jilin Province"). The samples were "natural samples" and "unaltered," indicating they were prospective or retrospectively collected real-world biological samples. Given the study took place in hospital settings, it implies a clinical context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. The ground truth was established by comparing the URITEST 50/500 results to those obtained from the Bayer Clinitek 50 and Clinitek 500 Urine Analyzers, which served as the reference method.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method in the traditional sense involving expert consensus for conflicting readings. The comparison was solely against the results from the predicate devices (Bayer Clinitek 50 and 500).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described in the provided text. The study involved instrumental readings of urinalysis strips by the URITEST devices and comparison to predicate devices, rather than an assessment of human reader performance with or without AI assistance. The study "demonstrated that professional users... can obtain valid urinalysis test results," but this refers to the usability and outcome when using the device, not an evaluation of human readers' diagnostic accuracy with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the study primarily functions as a standalone performance evaluation of the URITEST 50 and URITEST 500 instruments. It assesses the instruments' ability to read urinalysis strips and provide results, comparing these instrumental readings to those of predicate devices. While professional users are involved in operating the device and handling samples, the performance being measured is that of the analyzer itself, operating autonomously to interpret the strips.

7. The Type of Ground Truth Used

The ground truth for the test set was established by comparison to a legally marketed predicate device's results. Specifically, the results from the URITEST 50 and URITEST 500 were compared to those obtained from the Bayer Clinitek 50 and Clinitek 500 Urine Analyzers. This effectively uses the predicate devices' established performance as the "ground truth" or reference standard for equivalence.

8. The Sample Size for the Training Set

The document does not provide any information regarding a distinct training set sample size or how the device itself was trained. This implies that the device is a rule-based or spectrophotometric analyzer, not an AI/machine learning model in the modern sense that requires a separate training phase with labeled data. Its "training" would be through its design, calibration, and engineering specifications.

9. How the Ground Truth for the Training Set Was Established

As no training set is described for an AI/machine learning model, the concept of establishing ground truth for a training set does not apply in the context presented by this document for these devices. The device's operational parameters would have been set during its development and manufacturing, likely based on chemical reaction principles and calibration against known standards.

Ask a specific question about this device

URITEST 10 Urinalysis Reagent Strips provide qualitative and sem-quantitative tests for glucose, bilirubin, ketones (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogen, nitrites, and leukocytes in urine. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance, and bacteriuria.

ARJ Medical URITEST 10 Urinalysis Reagent Strips are for single use in professional near patient (point-of-care) facilities and centralized laboratory locations by medical technologists both read visually and on the Bayer Family of Clinitek Analyzers. The strips are intended of use in screening at-risk patients to assist diagnosis in the following areas:

Kidney Function Urinary Tract infections Carbohydrate metabolism Liver Function Acid-Base balance Urine Concentration

Test results can be used along with other diagnostic information to rule out certain disease states and to determine if microscopic analysis is needed.

URITEST 10 Urinalysis Reagent Strips provide qualitative and semi-quantitative for pH, specific gravity, ketones. blood, protein, nitrite, leukocytes, glucose, bilirubin, and urobilinogen in urine. URITEST 10 Urinalysis Reagent Strips are firm plastic, dry reagent strips. The reagent areas are dipped into the urine sample and read visually according to a color chart or are read instrumentally with a Bayer® Family of Clinitek Urine Analyzers. The results are available within 120 seconds. To obtain optimal results, it is necessary to use fresh, well-mixed and uncentrifuged urine.

The provided text describes the URITEST 10 Urinalysis Reagent Strips but lacks specific details regarding acceptance criteria and the comprehensive study methodologies typically found in a full submission. However, based on the available information, I can construct a response.

Acceptance Criteria and Device Performance Study

The document states that the performance of URITEST 10 Urinalysis Reagent Strips was compared to the legally marketed predicate device, Bayer MULTISTIX 10 SG Reagent Strips. The overarching acceptance criterion appears to be "performance comparable to that of Bayer MULTISTIX 10 SG Reagent Strips."

Since specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are not provided, I will infer that the reported performance implies a demonstration of equivalence or non-inferiority to the predicate device in terms of qualitative and semi-quantitative results for all ten analytes.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size: The document does not specify the exact sample size for the test set used in the clinical performance study. It only mentions "a clinical laboratory setting" for the study.
• Data Provenance: The data provenance is not explicitly stated in terms of country of origin. The study was conducted in a "clinical laboratory setting" and involved professional users in "centralized and point-of-care (POC) hospital clinical and doctor's office setting." It's reasonable to infer these settings are within the United States, given the FDA 510(k) submission. The study was prospective in nature as it involved collecting and testing urine samples using the URITEST 10 strips and comparing them to results from the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• The document does not state the number of experts or their specific qualifications for establishing ground truth for the test set. Instead, the "ground truth" for comparison was established by the results obtained from the Bayer MULTISTIX 10 SG reagent strips, which served as the reference standard in this equivalence study. The tests were read both visually and instrumentally by "professional users" (medical technologists).

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1). The "ground truth" was derived from the predicate device's results, with the URITEST 10 results being compared to them.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not conducted. This device is a traditional urinalysis reagent strip, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation in that context. The study did involve both visual and instrumental readings by professional users, but this is a standard practice for this type of device, not an AI assistance evaluation.

6. Standalone Performance Study (Algorithm Only)

• The concept of a "standalone (i.e., algorithm only without human-in-the-loop performance)" study is not applicable here. The device is a physical reagent strip that requires either visual interpretation by a human or instrumental reading (on Bayer Clinitek Urine Analyzers). It is not an algorithm that operates independently.

7. Type of Ground Truth Used

• The type of ground truth used was comparative performance against a legally marketed predicate device (Bayer MULTISTIX 10 SG Reagent Strips). This is a common approach for 510(k) submissions demonstrating substantial equivalence. The predicate device's results, obtained through standard laboratory methods and visual/instrumental readings by professionals, served as the reference.

8. Sample Size for the Training Set

• The document does not mention a "training set" in the context of device development. This terminology is typically associated with machine learning or AI algorithms, which are not described as part of this device's development or operation. The URITEST 10 is a chemical reagent-based test strip.

9. How Ground Truth for the Training Set Was Established

• As there is no mention of a "training set" for an algorithm, the question of how its ground truth was established is not applicable to this 510(k) summary.

Ask a specific question about this device

Pylo-Plus is intended for the qualitative detection of the urease enzyme in gastric I your id is intended for the presumptive determination of Helicobacter pylori in symptomatic patients. ARJ Medical's Pylo-Plus Rapid Urease Tests are for single use by medical and ANJ Medical 3 1 710 1 148 Rapia Created for use in screening at-risk patients to assist diagnosis in the field of Gastroenterology.

Pylo-Plus is a Rapid Urease Test.

The provided document is a 510(k) clearance letter from the FDA for the "Pylo-Plus" device and its Statement of Indications for Use. It does not contain the detailed information about acceptance criteria, study design, or performance metrics typically found in a clinical study report or a 510(k) summary.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods), or MRMC study results directly from these documents.

This type of information would typically be found in the 510(k) Summary (Section 510(k) Summary or 510(k) Statement) submitted by the manufacturer to the FDA, which often includes a summary of the clinical or analytical performance studies. The provided documents are the FDA's clearance letter and the "Indications for Use" statement, which confirm the device's clearance and intended use but not the underlying study data.

Ask a specific question about this device