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The Diagnostic Chemicals Limited Enzymatic Creatinine Assay is for the quantitative determination of creatinine in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This device is intended for professional use and IN VITRO diagnostic use only.

The Enzymatic Creatinine Assay contains an in vitro diagnostic reagent system intended for the quantitative determination of creatinine in serum, plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.

The provided document is a 510(k) summary for a medical device called the "Enzymatic Creatinine Assay." This document describes the device and its comparison to a predicate device, focusing on substantial equivalence for regulatory purposes. It does not present acceptance criteria in a quantitative, pre-defined manner typical of performance goals for a new device. Instead, it demonstrates performance by comparing its results to a legally marketed predicate device (Roche Diagnostics Corp. Creatinine Plus) and showing a high correlation.

Therefore, for this specific submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device through strong correlation and linearity in method comparison studies.

Here's the information extracted and structured based on your request, with an emphasis on how the information is presented in the provided context:

Acceptance Criteria and Study Details for Enzymatic Creatinine Assay (K070383)

This 510(k) submission demonstrates the substantial equivalence of the Enzymatic Creatinine Assay to a predicate device, the Roche Diagnostics Corp. Creatinine Plus (K003261). The "acceptance criteria" are not explicitly stated as quantitative thresholds for performance metrics (e.g., sensitivity > 90%). Instead, the study aims to show a strong correlation and agreement with the predicate device, thereby demonstrating equivalent performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Serum: 40 samples
• Urine: 40 samples
• Plasma vs. Serum: 33 samples
• Data Provenance: Not explicitly stated regarding country of origin. The study describes "a comparison was made between this method and a similar enzymatic method," or "a comparison was made between plasma and serum." The context of a 510(k) from a Canadian company (Diagnostic Chemicals Limited) seeking FDA approval suggests the data would be relevant to North American populations, but this is not definitively stated. It is a retrospective method comparison study, using existing samples to compare two methods.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not applicable/Not mentioned. This is a comparison of two diagnostic assays, where one (the predicate) serves as the reference or "ground truth" for evaluating the other. The "ground truth" is established by the existing, legally marketed predicate device's measured values, rather than by human expert interpretation of raw data.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods are typically used in studies where human readers interpret images or clinical data and their interpretations need to be reconciled by experts. In this analytical performance study comparing two quantitative assays, the comparison is directly between the numerical results generated by each assay. The statistical method used for comparison was Deming regression using NCCLS EP9-P.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study assesses the performance of human readers, with and without AI assistance, typically for image-based diagnostics. This submission is for an in vitro diagnostic (IVD) assay for chemical measurement, not an AI-powered diagnostic imaging device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Yes, a standalone performance study was done in the sense that the device's output (creatinine concentration) was directly compared to the predicate device's output. There is no human-in-the-loop component for the measurement of creatinine itself; the device automatically produces a quantitative result. The study evaluated the analytical performance of the new assay in isolation (i.e., its ability to accurately measure creatinine compared to a reference method).

7. Type of Ground Truth Used

• The "ground truth" in this context is the measurements obtained from the predicate device (Roche Diagnostics Corp. Creatinine Plus). The study aimed to demonstrate that the new Enzymatic Creatinine Assay produces results that are highly correlated and essentially interchangeable with those from the established predicate method.

8. Sample Size for the Training Set

• The document describes a method comparison study for showing substantial equivalence, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The samples mentioned above (40 serum, 40 urine, 33 plasma) comprise the samples used to test the performance of the new device relative to the predicate.

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

• As there is no training set for an AI/ML model, this question is not applicable. For the performance evaluation, the "ground truth" was established by the measurements provided by the predicate device.

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The Diagnostic Chemicals Limited Magnesium Assay (XB) is for the quantitative determination of magnesium in human serum. Magnesium measurements are used in the diagnosis and treatment of hypomagnesemia (abnormally low levels of magnesium) and hypermagnesemia (abnormally high levels of magnesium). This device is intended for professional use and IN VITRO diagnostic use only.

The Diagnostic Chemicals Limited Magnesium Assay (XB) Standard is used for the callbration of the Diagnostic Chemicals Limited Magnesium Assay (XB) when used for the quantitative determination of magnesium in human serum.

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The provided text is a 510(k) premarket notification acceptance letter from the FDA for a Magnesium Assay (XB) device. It confirms the device's substantial equivalence to legally marketed predicate devices. However, this document does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

The information requested in your prompt (e.g., acceptance criteria table, sample sizes, ground truth establishment, MRMC studies) is typically found in the technical documentation submitted by the manufacturer as part of the 510(k) application, not in the FDA's acceptance letter itself.

Therefore, I cannot fulfill your request with the provided input. The document mainly states that the device was reviewed and found substantially equivalent, but it doesn't elaborate on how that determination was made in terms of specific performance data and criteria.

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For the quantitative determination of C-reactive protein (CRP) in serum. For IN VITRO diagnostic use.

A CRP test system is a device intended to measure CRP in serum. C-Reactive Protein (CRP) is an abnormal protein synthesized in the liver during inflammation and necrosis of cellular tissue. This method, using antihuman CRP mouse antibody coated latex to bind CRP, allows for accurate measurement over a wide range of CRP concentrations. The resulting agglutination from binding is measured spectrophotometrically and is proportional to the concentration of CRP in the sample.

The provided text is a 510(k) premarket notification approval letter for a device called "CRP-ADVANCE." It describes the device's indications for use and general regulatory information but does not contain a study report or detailed acceptance criteria with performance results.

Therefore, I cannot extract the information required in your request regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on regulatory approval based on substantial equivalence to a predicate device.

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For the IN VITRO diagnostic use as calibrators for the DCL CRP-ADVANCE Assay for the quantitation of C-reactive protein in serum.

The CRP-ADVANCE Multi-Calibrator Set, Cat. No. SE-250 are C-reactive protein standards containing known quantities of human c-reactive protein. These calibrators are to be use with the DCL CRP-ADVANCF Assay.

The provided document is a 510(k) premarket notification letter from the FDA regarding a CRP-ADVANCE Multi-Calibrator Set. This device is a calibrator used for in vitro diagnostic assays to quantify C-reactive protein in serum.

Given the nature of this device (a calibrator, not an AI/ML-driven diagnostic device or imaging device), the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, as typically applied to AI/ML or imaging diagnostics, is largely not applicable or would be addressed through different types of validation studies (e.g., analytical validation studies for calibrators).

Nevertheless, I will interpret the request based on the information that can be inferred or is typically required for such a device.

Here's an attempt to answer the questions, highlighting when information is not present in the provided document or is not applicable to this type of device:

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

The provided document (an FDA 510(k) clearance letter) does not contain detailed acceptance criteria or detailed performance data from a specific study. Instead, it states that the device is "substantially equivalent" to a legally marketed predicate device. For a calibrator, acceptance criteria would typically revolve around its ability to:

• Accurately assign values (e.g., target concentrations of C-reactive protein).
• Demonstrate stability over its shelf life.
• Show lot-to-lot consistency.
• Be compatible with the intended assay (DCL CRP-ADVANCE Assay).

The "reported device performance" is essentially the FDA's determination of substantial equivalence, meaning it performs as intended and is as safe and effective as the predicate device. Specific numerical performance metrics are not provided in this regulatory letter but would have been part of the 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the FDA 510(k) clearance letter. For a calibrator, a "test set" wouldn't typically involve patient data in the way an AI diagnostic would. Instead, it would involve:

• A set of calibrator lots (for lot-to-lot variability studies).
• Reference materials or samples with known C-reactive protein concentrations (to verify assigned values).
• Samples tested on the DCL CRP-ADVANCE Assay using the calibrators.

The provenance (country, retrospective/prospective) is also not specified.

3. 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)

This is not applicable in the context of this device. Calibrators do not have "ground truth" in the sense of expert human interpretation of images or clinical data. The "ground truth" for a calibrator would be its assigned concentration of C-reactive protein, which is established through rigorous analytical methods, often traceable to international reference standards or highly precise laboratory measurements, not subjective expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a calibrator. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers/experts when establishing ground truth for diagnostic decisions, typically in imaging or clinical scenarios.

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 is not applicable to a calibrator. MRMC studies are used for evaluating diagnostic devices, especially those involving human interpretation, often in the context of AI assistance. A calibrator is a foundational component of an assay; it doesn't involve human 'readers' or 'cases' in this manner, nor does it involve AI.

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

This is not applicable to a calibrator. A calibrator is a physical reagent set, not an algorithm, and does not have a "standalone performance" in the context of AI. Its performance is demonstrated through its ability to accurately calibrate an assay.

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

For a calibrator, the "ground truth" for its values (C-reactive protein concentrations) would be established by:

• Traceability to a primary reference material or standard: Often established through highly accurate analytical techniques, possibly gravimetric or spectroscopic methods, benchmarked against international standards.
• Value assignment studies: Using precise analytical methods within a well-controlled laboratory environment to determine the concentration of the analyte in each calibrator level.

This is a measured, analytically derived ground truth, not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This is not applicable to a calibrator in the way it applies to AI/ML devices. Calibrators are not "trained" on data. Their formulation and characteristics are developed through chemical and biological engineering, and their values are assigned through analytical validation.

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

This is not applicable as there is no "training set" for a calibrator. The "ground truth" of the calibrator's assigned values is established through the analytical methods described in point 7.

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For the quantitative determination of Total Calcium in serum, plasma (Lithium Heparin) and urine. For IN VITRO diagnostic use.

Identification. A calcium test system is a device intended to measure total calcium in serum, plasma (Lithium Heparin) and urine. Calcium measurements are used in the diagnosis and treatment of hypercalcemia as a result from hyperparathyroidism, hypervitaminosisD, multiple myeloma and some neoplastic diseases of the bones. It is also used in the diagnosis and treatment of hypocalcemia as a result from hypoparathyroidism, steatorreah, nephritis and pancreatitis

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the Calcium ADVANCE Assay. It acknowledges the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

The information you are asking for, such as specific acceptance criteria for performance, sample sizes used in testing, details about ground truth establishment, or information about MRMC studies, would typically be found in the actual 510(k) submission document itself, which is often a large technical file not publicly released in its entirety in this format. The letter only states that the device is deemed "substantially equivalent" for the stated indications of use.

Therefore, I cannot provide the requested information based on the text provided.

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For the quantitative determination of low levels of albumin in urine. For IN VITRO diagnostic use.

The DCL Microalbumin Assay uses an immunoturbidimetric format which provides the sensitivity required for accurate determination of urinary microalbumin.

The provided text describes a 510(k) premarket notification for a device named "Microalbumin Assay" (Cat. No. 252-2) by Diagnostic Chemicals Limited. This device is intended for the quantitative determination of low levels of albumin in urine for in vitro diagnostic use.

The document does not contain any information regarding acceptance criteria, reported device performance, specific studies demonstrating the device meets acceptance criteria, sample sizes, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance studies, or details on how ground truth was established for either training or test sets.

The provided text is a standard FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms that the FDA has found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It discusses the general medical context of microalbuminuria and the device's technical approach (immunoturbidimetric format).

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or ground truth information based solely on the provided text. This information would typically be found in the 510(k) submission itself, in a separate study report, or a detailed technical manual, none of which are included in the given document.

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The Diagnostic Chemicals Limited's Acetaminophen-SL Assay is an in vitro diagnostic device intended to measure acetaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose. This assay consists of two reagents and a calibrator.

This assay consists of two reagents and a calibrator.

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Acetaminophen-SL Assay". This document primarily focuses on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices.

The information required to answer your request, such as detailed acceptance criteria, specific study designs, sample sizes for test and training sets, expert qualifications, and detailed performance metrics, is not present within this regulatory letter.

Therefore, I cannot extract the requested information from the provided text.

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The Diagnostic Chemicals Limited's Salicylate method is an in vitro diagnostic device intended to measure salicylate levels in human serum or plasma (Lithium heparin). intended to modellio balleyfato to the diagnosis of salicylate toxicity and overdose.

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The provided text is a 510(k) clearance letter for a Salicylate test system. This type of document does not typically contain the detailed information requested regarding acceptance criteria, study design, or ground truth establishment relevant to AI/ML device performance.

The letter confirms that the device, Salicylate, Cat.Nos.511-20 and 511-40, is substantially equivalent to legally marketed predicate devices for measuring salicylate levels in human serum or plasma to aid in the diagnosis of salicylate toxicity and overdose.

Therefore, I cannot provide the requested information based on the input text. The information is pertaining to a traditional in vitro diagnostic device, not an AI/ML device which would involve specific performance metrics and validation studies against a ground truth as outlined in your request.

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For the quantitative determination of carbon dioxide in serum and plasma. For IN VITRO diagnostic use.

The DCL Carbon Dioxide L3K® assay is an enzymatic procedure, employing phosphoenolpyruvate carboxylase (PEPC) (2) and a stabilized NADH analog (3), which is easy to use and applicable to routine laboratory instrumentation.

I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a Carbon Dioxide-L3K Assay. It confirms the substantial equivalence of the device to legally marketed predicate devices and outlines regulatory requirements.

This document does not contain information about:

• Acceptance criteria and reported device performance in a table format.
• Sample sizes, data provenance, or details about test sets.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Results of multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

Therefore, I cannot fulfill your request based on the provided input.

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For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

Not Found

The provided text is an FDA 510(k) clearance letter for the "LDL-ADVANCE Assay, Cat. No. 279-20, 279-40". This document is a regulatory approval and does not contain the detailed study information or acceptance criteria typical for a device performance evaluation. It primarily states that the device is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.

Specifically, the document states:

• Device Name: LDL-ADVANCE Assay, Cat. No. 279-20, 279-40
• Indications for Use: "For the quantitative determination of low density lipoprotein fractions of cholesterol in serum. For IN VITRO diagnostic use. A lipoprotein test system is a device intended to measure lipoprotein in serum. Low Density Lipoprotein (LDL) cholesterol measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases."

Without a separate clinical or performance study report, it's impossible to answer the specific questions about acceptance criteria, reported performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.

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