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The intended use for the N-ASSAY Glu-UL Reagent is for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma. For in vitro diagnostic use only.

The N-ASSAY Glu-UL reagent is based on an enzymatic hexokinase/glucose-6phosphate dehydrogenase method, shows good correlation with similar glucose reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is a convenient ready-to-use liquid type reagent.

In this method, serum D-glucose is phosphorylated by hexokinase (HK) in the presence of adenosine triphosphate (ATP) to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate (ADP). Glucose-6-phosphate dehydrogenase (G-6-PDH) specifically oxidizes G-6-P to 6-Phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The increase in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of the NADPH, is directly proportional to the glucose concentration in the sample.

The provided text describes a 510(k) submission for the N-ASSAY Glu-UL (Glucose Assay Reagent). It details the device's function and provides comparison studies against predicate devices to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for correlation coefficients or regression equations. Instead, it demonstrates "substantial equivalence" to predicate devices, implying that the performance must be comparable to these already marketed devices.

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

The document does not explicitly state the sample sizes used for the comparison studies for serum, urine, or CSF samples. It only mentions "serum samples," "urine samples," and "CSF samples" in a general sense.

The data provenance is not explicitly mentioned (e.g., country of origin, retrospective or prospective). However, given the context of a 510(k) submission for a diagnostic reagent, it is highly likely these were prospective laboratory studies.

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

This information is not applicable in this context. The "ground truth" for a quantitative diagnostic reagent like N-ASSAY Glu-UL is typically established by:

• Reference Methods: Highly accurate and precise laboratory methods.
• Predicate Device Results: The results obtained from the legally marketed predicate devices are used as the comparative "truth" to assess the performance of the new device.

There were no human experts evaluating images or making diagnoses against which the device's output would be compared.

4. Adjudication Method for the Test Set

This information is not applicable. Since the "ground truth" is established by reference methods or predicate device results, there is no need for expert adjudication. The comparison is made directly between the quantitative results of the new device and the predicate device.

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

This information is not applicable. An MRMC study is relevant for diagnostic imaging devices where human readers interpret images, often with and without AI assistance. The N-ASSAY Glu-UL is a chemical reagent for quantitative blood and fluid analysis, not an imaging device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The studies described are inherently "standalone" in the sense that they evaluate the performance of the reagent itself (which is analogous to an "algorithm" in a chemical assay) against predicate methods. There is no "human-in-the-loop" aspect being evaluated in these comparison studies; the studies assess how well the reagent performs in generating quantitative results.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for the comparison studies was the results obtained from the predicate devices:

• For serum samples: Medical Analysis Systems Glucose liquid reagent (K853464)
• For urine and CSF samples: Boehringer Mannheim Glucose assay (K812303)

These predicate devices are themselves established glucose measurement methods.

8. The sample size for the training set

The document does not provide information on a "training set" for the N-ASSAY Glu-UL reagent. This is because the device is a chemical reagent, not a machine learning or AI-based system that typically requires a training set. The performance is based on the chemical reactions and optical detection, which are inherent properties of the reagent's formulation.

9. How the ground truth for the training set was established

As there is no mention of a "training set" for this chemical reagent, this information is not applicable. The ground truth for evaluating the reagent's performance (as described in point 7) was established by comparing its results to established predicate methods.

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The intended use for the N-ASSAY L D-BIL Reagent is for the quantitative measurement of direct bilirubin in human serum in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.

The N-ASSAY L D-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar direct bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. In this method, a serum sample containing direct bilirubin is mixed with the reagent containing sodium nitrite. Direct billrubin is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the direct bilirubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.

Here's a breakdown of the acceptance criteria and study information for the N-ASSAY L D-BIL (Direct Bilirubin Assay Reagent), based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The text mentions "serum samples" for the correlation study but doesn't provide the number of samples.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission for a diagnostic device, the samples would typically be human serum. It's not specified if they were retrospective or prospective, nor their country of origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This is not a study requiring expert interpretation of images or other qualitative data. The comparison is against a legally marketed predicate device using quantitative measurements.

4. Adjudication method for the test set:

• Not applicable. This is not a study requiring adjudication of expert opinions. The comparison is analytical performance against a predicate device.

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:

• No. This is a 510(k) submission for an in vitro diagnostic reagent, not an AI-based imaging or analytical device that would involve human readers or AI assistance in interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, implicitly. The performance metrics (correlation, precision, minimum detectable level, linearity) describe the analytical performance of the N-ASSAY L D-BIL reagent itself, without human intervention in the measurement process after sample introduction. It's a "device only" performance assessment.

7. The type of ground truth used:

• The "ground truth" for the comparison study was the measurements obtained from the predicate device, the WAKO Chemicals Direct Bilirubin liquid reagent (K970986). The study aimed to demonstrate substantial equivalence by correlating the new device's results with the predicate's results.

8. The sample size for the training set:

• Not applicable. This is a chemical reagent, not an algorithm that requires a training set in the sense of machine learning. The "development" would involve chemical formulation and optimization, not data training.

9. How the ground truth for the training set was established:

• Not applicable, as there's no training set in the context of an algorithm.

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The intended use for the N-ASSAY L T-BIL Reagent is for the quantitative determination of serum Total Bilirubin in the diagnosis and treatment of various liver diseases. For in vitro diagnostic use only.

The N-ASSAY L T-BIL reagent is based on a chemical oxidation method, utilizing sodium nitrite as an oxidizing agent, shows good correlation with similar Total Bilirubin reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.

In this method, a serum sample containing total bilirubin is mixed with the reagent containing sodium nitrite. Total bilirubin (direct bilirubin) is oxidized by nitrite at pH 3.7 to produce biliverdin which causes the absorbance at 450 nm (main) and 546 (sub), specific to bilirubin, to decrease. Therefore, the total billinubin concentration in the sample can be obtained by measuring the absorbance before and after the sodium nitrite oxidation.

Acceptance Criteria and Study for Crestat N-ASSAY L T-BIL Reagent

This medical device is a diagnostic reagent for measuring total bilirubin. The provided text describes a 510(k) submission, focusing on establishing substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state pre-defined acceptance criteria values in the format of a typical performance goal. Instead, the study aims to demonstrate substantial equivalence to a predicate device. The performance metrics reported are for comparison to this predicate.

Note: The "acceptance criteria" are inferred based on demonstrating substantial equivalence, meaning the performance should be very similar to or better than the predicate's known performance.

2. Sample Size and Data Provenance

• Test Set Sample Size: Not explicitly stated. The text mentions "serum samples" were used in comparison studies against the predicate.
• Data Provenance: Not explicitly stated. Given it's a 510(k) from 1998 in the US, it's highly likely the data was collected in the US. It's also typical for such studies to be prospective, but this is not explicitly stated.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for this type of in vitro diagnostic device is typically established against a reference method or by comparison to a legally marketed predicate device, rather than expert consensus on individual cases.

4. Adjudication Method

Not applicable. No expert adjudication method is described as the study focuses on quantitative measurement and comparison to a predicate device.

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

No. This is an in vitro diagnostic (IVD) reagent, and MRMC studies are typically performed for imaging or qualitative diagnostic devices where human interpretation is a key component. The effectiveness study here is based on quantitative analytical performance against a predicate.

6. Standalone Performance Study

Yes, the analytical performance (correlation coefficient, regression equation, precision, minimum detectable level, linearity, interference, reproducibility, sensitivity, assay range) of the N-ASSAY L T-BIL reagent was evaluated on its own and compared to the predicate device. This constitutes a standalone performance evaluation in the context of IVD reagents.

7. Type of Ground Truth Used

The ground truth was established by comparison to a legally marketed predicate device, specifically the WAKO Chemicals Total Bilirubin liquid reagent (K970985). This predicate device serves as the "reference standard" against which the new device's performance is measured to demonstrate substantial equivalence.

8. Sample Size for the Training Set

Not applicable. This is an analytical device for measuring a biochemical marker. There is no "training set" in the machine learning sense. The device's performance is determined by its chemical reagents and reaction principles, which are developed through R&D, not by training on a dataset.

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

Not applicable, as there is no training set mentioned or implied for this type of device.

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The intended use for the N-ASSAY L AST/GOT Reagent is for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum in the diagnosis and treatment of certain types of liver, heart, and muscle diseases. For in vitro diagnostic use only.

The N-ASSAY L AST/GOT reagent is based on an the optimized enzymatic AST kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar AST reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent.

In this procedure, L-Aspartic Acid and a-Ketoglutaric Acid are translated by aspartate aminotransferase (AST) to produce Oxalacetic Acid and Glutamic Acid. Oxalacetic Acid is reduced by Malic Dehydrogenase to produce Malic Acid with the concurrent oxidation of nicotinamide adenine dinucleotide reduced (NADH) to nicotinamide adenine dinucleotide (NAD). The NADH absorbs light at 340 nm (main) and 405 nm (sub) and can be detected spectrophotometrically. The decrease per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the decrease of NADH, is directly proportional to the AST activity in the sample.

The Crestat N-ASSAY L AST/GOT Reagent is an in vitro diagnostic device used for the quantitative determination of serum aspartate aminotransferase (AST) activity in human serum, aiding in the diagnosis and treatment of certain liver, heart, and muscle diseases.

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not explicitly state the number of samples used in the comparison studies. It refers to "serum samples" in plural, implying more than one but providing no specific quantity.
• Data Provenance: Not explicitly stated. However, given that it's an in vitro diagnostic device for human serum, it's highly probable the samples were from human patients. The country of origin and whether the data was retrospective or prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The concept of "ground truth" in the context of expert consensus isn't directly applicable here in the same way it would be for image analysis or disease diagnosis. For this device, the "ground truth" for the test set is established by the performance of the predicate device (Boehringer Mannheim Corporation AST liquid reagent). The predicate device itself would have undergone its own validation based on established clinical chemistry methods.
• Therefore, there were no experts explicitly used to establish ground truth for this device's test set in the manner of adjudication. The predicate device's results are considered the reference.

4. Adjudication method for the test set:

• None. Adjudication is typically used when human interpretation of data is involved to establish a consensus ground truth. In this case, the test involved comparing the quantitative results of the new device against a predicate device, which is an objective measurement comparison.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. An MRMC study is not relevant for this type of quantitative diagnostic assay. MRMC studies are primarily for evaluating the diagnostic performance of human readers, often with and without AI assistance, especially in image-based diagnostics. This study focuses on the analytical performance of a chemical reagent.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Yes, this was a standalone study. The N-ASSAY L AST/GOT Reagent is a chemical assay, and its performance was evaluated intrinsically by comparing its quantitative results to a predicate device. There is no "human-in-the-loop" component in the direct measurement process being evaluated here, beyond standard laboratory handling and operation.

7. The type of ground truth used:

• The "ground truth" in this context is the results obtained from the predicate device (Boehringer Mannheim Corporation AST liquid reagent). This predicate device itself is considered a well-established and validated method for measuring AST activity.

8. The sample size for the training set:

• The concept of a "training set" in the machine learning sense is not applicable to this chemical reagent. There is no algorithm that is "trained" on data. The reagent's performance is based on its chemical properties and optimized enzymatic method. Therefore, no training set was used.

9. How the ground truth for the training set was established:

• As there is no training set for this chemical assay, the question of how its ground truth was established is not applicable.

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The intended use for the N-ASSAY CPK-L Reagent is for the quantitative determination of serum creatine phosphokinase (CPK) activity in human serum in the diagnosis and treatment of myocardial infarction and muscle diseases such as muscular dystrophy.

The N-ASSAY CPK-L reagent is based on an optimized CPK kinetic method as recommended by the Japan Society of Clinical Chemistry, shows good correlation with similar CPK reagents, practically no interference by coexistent substances, high sensitivity with good reproducibility, wide assay range, and is convenient ready-to-use liquid type reagent. The N-ASSAY CPK-L reagent utilizes an enzymatic method. In this procedure, creatine phosphate is dephosphorylated by creatine phosphokinase (CPK) in the presence of adenosine disphosphate (ADP) to produce creatine and adenosine triphosphate (ATP). ATP is dephosphorylated by hexokinase in the presence of D-glucose to produce glucose-6-phosphate (G-6-P) and adenosine diphosphate. Glucose-6-phosphate dehydrogenase specifically oxidizes G-6-P to 6-phosphogluconate with the concurrent reduction of nicotinamide adenine dinucleotide phosphate (NADP) to nicotinamide adenine dinucleotide phosphate reduced (NADPH). The NADPH produced absorbs light at 340 nm (main) and 405 (sub) and can be detected spectrophotometrically. The increase per minute in absorbance measured at 340 nm (main) and 405 (sub), due to the formation of NADPH, is directly proportional to CPK activity in the sample.

Here's an analysis of the provided text regarding the acceptance criteria and study for the CRESTAT N-ASSAY CPK-L Reagent:

Acceptance Criteria and Device Performance

The provided document describes the safety and effectiveness of the N-ASSAY CPK-L Reagent in relation to a predicate device, the Medical Analysis Systems CK liquid reagent (K781719). The acceptance criteria for this type of medical device are generally framed around demonstrating substantial equivalence to a legally marketed predicate device.

Table of Acceptance Criteria and Reported Device Performance

Study Details

The information provided describes a comparison study to demonstrate substantial equivalence to a predicate device.

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document mentions "serum samples" but does not specify the exact number of samples used in the comparison study.
   • Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state if the study was retrospective or prospective, but comparison studies for K510 submissions often involve collecting prospective samples or using banked samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This type of study (comparing a new in-vitro diagnostic reagent against a predicate reagent) does not typically involve human expert adjudication for image interpretation. The "ground truth" is established by the performance of the predicate device. Therefore, no information is provided on experts or their qualifications for establishing ground truth in this context.

3. Adjudication method for the test set:

   • Not applicable as this is a comparison study between two in-vitro diagnostic reagents, not an interpretation task requiring expert adjudication.

4. 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. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting cases. It is an in-vitro diagnostic reagent.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. The performance metrics (correlation, regression, minimum detectable level, linearity, precision) are all derived from the performance of the reagent itself, a "standalone algorithm" in the context of an in-vitro diagnostic. There is no human-in-the-loop component for the measurement itself; the human only performs the assay.

6. The type of ground truth used:

   • The "ground truth" in this context is the results obtained from the predicate device (Medical Analysis Systems CK liquid reagent, K781719). The study seeks to show that the new device's results are substantially equivalent to those of the predicate.

7. The sample size for the training set:

   • The document does not explicitly describe a "training set" in the sense of modern machine learning. For an in-vitro diagnostic reagent, the "training" involves the development and optimization of the reagent formulation and assay parameters based on known chemical principles and experimental trials. The specific sample size for this development phase is not provided.

8. How the ground truth for the training set was established:

   • Not directly applicable in the sense of a medical imaging or AI model "training set." The "ground truth" during the development of this chemical reagent would have been established through well-characterized reference materials, known concentrations of CPK, and established laboratory methods to ensure the reagent's components and reactions are functioning as expected to accurately measure CPK activity.

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The intended use for the N-Assay TIA Antithrombin III Test Kit is for the quantification of human antithrombin III in human plasma. AT- III levels less than 60% of normal are associated with increased risk of thromboembolism. The assay of plasma AT-TII is also helpful in monitoring heparin therapy.

Not Found

The provided document is a 510(k) clearance letter from the FDA for the "N-Assay TIA Antithrombin III Test Kit." This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about acceptance criteria or specific study results in the format requested.

Therefore, I cannot provide the requested information from the given text.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size or ground truth establishment for the training set.

The document mainly focuses on the regulatory aspects of the device, its intended use (quantification of human antithrombin III in human plasma, association of low levels with thromboembolism risk, and monitoring heparin therapy), and its classification as substantially equivalent.

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The N-Assay TIA Plasminogen Test Kit is intended to be used for the squantitation of plasminogen in in human plasma by immuno-turbidimetric assay. Decreased levels of plasminogen are of clinical importance. Low levels of plasminogen are usually due to liver disease with impaired synthesis, or to increased utilization associated with DIC(disseminated intravascular coaculation). Low levels could also occur in severe nephrosis. Measurement of plasminogen is helpful in the diagnosis of these conditions.

N-Assay TIA Plasminogen Test Kit

I am sorry, but the provided text does not contain specific information about acceptance criteria, device performance, sample sizes for test or training sets, expert qualifications, or adjudication methods for the "N-Assay TIA Plasminogen Test Kit."

The document is a 510(k) clearance letter from the FDA, indicating that the device is substantially equivalent to legally marketed predicate devices. It discusses the regulatory classification, general controls, and compliance requirements. It also states the intended use of the device for the quantitation of plasminogen in human plasma by immunoturbidimetric assay and highlights the clinical importance of plasminogen levels.

However, it does not include the detailed technical performance data or study results that would be necessary to populate a table of acceptance criteria and reported performance, or to answer the specific questions about the study design and ground truth establishment.

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The N-Assay TIA Apoprotein A-l Test Kit is intended to be used for the quantitative determination of human apoprotein a successor and in numan serum by immunoturòid assay. The measurement in numan serum by immunoturòid assay. The measurement in numan serum by immondtoldimetric assay. The meadershow. of apoprotein A-l is useful in the diagnosis of atherosclerosis.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the N-Assay TIA Apolipoprotein A-1 Test Kit. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the device's accuracy or effectiveness.

Therefore, I cannot fulfill your request for the specific details about acceptance criteria and the study proving the device meets them based on the provided input.

The document mainly focuses on the regulatory aspects of the device's clearance for marketing.

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The N-Assay TIA Apoprotein A/B Calibrator is intended to be used for the calibration of the Crestat Diagnostics N-Assay TIA Apoprotein A-1 and Apoprotein B Test Kits. which are immuno turbidimetric assays for the measurement of Apo Apoprotein A-1 and Apoprotein B in human serum.

Not Found

I am sorry, but based on the provided document, the information required to answer your request is not present. This document is an FDA 510(k) clearance letter for a medical device (N-Assay® A-1/B MULTI Calibrator Set), which primarily confirms substantial equivalence to a predicate device and outlines regulatory obligations.

The document does not contain:

• A table of acceptance criteria and reported device performance.
• Details about a study proving the device meets acceptance criteria.
• Information on sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

These details are typically found in the 510(k) submission itself or in separate technical documentation and clinical study reports, which are not included in this clearance letter.

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The N-Assay TIA APO B Test Kit is intended to be used for the quantitative determination of human apolipoprotein B in human serum by immunoturbidimetric assay. The measurement of Apolipoproteinbis useful in the diagnosis of atherosclerosis.

Not Found

This letter from the FDA is an approval for a medical device (N-Assay® TIA Apolipoprotein B Test Kit) and does not contain the information requested regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications.

The letter explicitly states that the FDA "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This indicates a substantial equivalence (510(k)) pathway, which means the device was found to be as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies and acceptance criteria as would be needed for a Premarket Approval Application (PMA) for a novel device.

Therefore, I cannot fulfill your request using the provided text.

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