Search Results

The Diazyme Lp(a) is intended as a latex particle enhanced immunoturbidimetric assay for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum er plasma (EDTA) on Clinical Chemistry Systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular diseases in specific populations, when used in conjunction with clinical evaluation.

Diazyme Lp(a) Control is intended for use in monitoring the quality control of results obtained with the Diazyme Lp(a) reagents by turbidimetry.

Diazyme Lp(a) standard is intended for use in establishing the calibration curve for the Diazyme Lp(a) reagents by turbidimetry.

The Diazyme Lipoprotein (a) Assay is based on a latex enhanced immunoturbidimetric assay. Lp(a) in the sample binds to specific anti-Lp(a) antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Lp(a) in the sample.

Here's a breakdown of the acceptance criteria and the study details for the Diazyme Lp(a) Assay, based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the Diazyme Lp(a) Assay by comparing its performance to a predicate device (Denka Lp(a) Assay) and reporting specific performance characteristics such as precision and accuracy. The "acceptance criteria" are implied by the performance of the legally marketed predicate device and the new device demonstrating "good agreement" and "substantially similar" results.

Note: The acceptance criteria are based on demonstrating "substantial equivalence" to the predicate device. This implies that the new device's performance should be comparable and within acceptable analytical limits, which are not explicitly defined as numerical thresholds beyond the reported performance metrics. The statement "good agreement with legally marketed assay" and "no significant deviation" act as the overarching acceptance criteria for accuracy.

Study Details

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

   • Test Set Sample Size:
     • Accuracy (Correlation studies): 76 serum samples.
     • Precision: Three levels of serum specimens. While not explicitly stating the number of unique patient samples, the study design involved testing these three levels with 2 runs per day, with duplicates, over 20 working days.
     • Interference: Human serum samples were used, but the exact number is not specified.
   • Data Provenance: Not explicitly stated, but the samples are "human serum" and "human plasma." There is no mention of country of origin or whether the data was retrospective or prospective.

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

   • This device is an in vitro diagnostic assay that quantifies a biomarker (Lp(a)). The "ground truth" for such assays is typically established by comparative methods, such as a legally marketed predicate device or a reference method. It does not involve human expert interpretation of images or clinical findings in the same way as, for example, a radiology AI device. Therefore, no information on human experts establishing ground truth for the test set or their qualifications is provided or relevant in this context.

3. Adjudication method for the test set:

   • Not applicable. As explained above, this is a quantitative diagnostic assay where the "ground truth" is typically the result from a reference method or predicate device, not subject to human expert adjudication. The comparison method is direct measurement against the predicate device.

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:

   • Not applicable. This is an in vitro diagnostic assay, not an AI-powered diagnostic imaging device that assists human readers. Therefore, an MRMC study and AI-assisted performance improvement are not relevant.

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

   • Yes, this is primarily a standalone device performance study. The Diazyme Lp(a) Assay is an automated quantitative assay. The reported performance metrics (precision, accuracy, interference) are for the device itself operating without human interpretation of its primary output beyond standard laboratory procedures for running an assay. The comparison against the predicate device reflects the standalone performance.

6. The type of ground truth used:

   • The "ground truth" for the accuracy study was established by comparison with an existing commercial Lp(a) assay method (the predicate device, Denka Lp(a) Assay, K013359). This is a common method for establishing accuracy and substantial equivalence for in vitro diagnostic devices.

7. The sample size for the training set:

   • No information about a "training set" is provided. This is typical for in vitro diagnostic assays based on chemical/immunological reactions, as they are not machine-learning algorithms that require a training phase with labeled data in the same way an AI device does. The device's performance characteristics are determined through analytical validation studies (precision, accuracy, interference, linearity, etc.).

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

   • Not applicable, as no training set for an AI/machine learning algorithm is mentioned or relevant for this type of in vitro diagnostic device.

Ask a specific question about this device

The Diazyme Apolipoprotein A-I Assay is intended for the in vitro quantitative determination of apolipoprotein A-I (apo A-I) in serum. It can be used as an aid for assessing the risk of coronary artery disease. For in vitro Diagnostic use.

Calibrator: For calibration of the Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.

Controls: To monitor the performance of Diazyme Apolipoprotein A-I Assay in serum. For in vitro Diagnostic Use.

This method is based on the reaction of a sample containing human Apo A-I and specific antiserum to form an insoluble complex which can be measured turbidimetrically at 340nm. By constructing a standard curve from the absorbance of standards the concentration of Apo A-1 can be determined.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Diazyme Apolipoprotein A-I Assay:

It's important to note that this document is a 510(k) summary for a diagnostic assay, not a device with AI/ML components. Therefore, many of the requested fields related to AI/ML specific studies (MRMC, standalone algorithm performance, training/test set sample size for AI, ground truth establishment for AI) are not applicable and will be marked as such. The "acceptance criteria" here refer to performance specifications demonstrating substantial equivalence to a predicate device.

Acceptance Criteria and Device Performance

Study Proving Acceptance Criteria:

The Diazyme Apolipoprotein A-I Assay demonstrated substantial equivalence to the K-Assay Apo AI Assay by providing performance data within acceptable ranges or showing improvement compared to the predicate device's reported specifications.

Additional Information:

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

   • Sample Size: Not explicitly stated in the provided 510(k) summary for each performance metric. For diagnostic assays, this information is typically found in the full submission.
   • Data Provenance: Not specified, but generally, such studies for in-vitro diagnostics use human serum samples. The country of origin and whether it's retrospective or prospective is not mentioned.

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

   • Not Applicable. For this type of in-vitro diagnostic assay, "ground truth" is typically established by reference methods or validated comparative assays, not by expert consensus in the way it applies to image analysis or clinical diagnosis. The "ground truth" here is the actual concentration of Apo A-I in the samples, as determined by a reference method or the predicate device that itself has established accuracy.

3. Adjudication method for the test set:

   • Not Applicable. Adjudication typically refers to resolving discrepancies among multiple human readers, which is not relevant for an automated chemical assay.

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 an in-vitro diagnostic assay, not an AI-assisted diagnostic tool.

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

   • Yes, by its nature. The performance data presented (reportable range, precision, accuracy) reflects the standalone performance of the Diazyme Apolipoprotein A-I Assay system as an automated chemical assay. There is no human-in-the-loop component relevant to the assay's core function of measuring Apo A-I concentration; humans load samples and interpret results, but the measurement itself is automated.

6. The type of ground truth used:

   • Comparative method/Reference Standard. The "ground truth" for calibrator value traceability is stated as the "WHO International Reference Material for Apo AI, Sp1-01." For assay accuracy, it's typically established by comparing results against a predicate device (K-Assay Apo AI Assay in this case) or another established reference method, where the predicate itself serves as a highly accurate measure for comparison, or against samples with known concentrations derived from a reference method.

7. The sample size for the training set:

   • Not Applicable. This is not an AI/ML device that requires a training set in the conventional sense. The "training" for a chemical assay involves optimizing reagents and protocols.

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

   • Not Applicable. See point 7.

Ask a specific question about this device

The Diazyme LDL-Cholesterol Assay is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.

The assay is based on a modified polyvinyl sulfonic acid (PVS) and polyethylene-glycol methyl ether (PEGME) coupled classic precipitation method with the improvements in using optimized quantities of PVS/PEGME and selected detergents. LDL, VLDL. and chylomicron (CM) react with PVS and PEGME and the reaction results in inaccessibility of LDL, VLDL and CM by cholesterol oxidase (CHOD) and cholesterol esterase (CHER), whereas HDL reacts with the enzymes. Addition of R2 containing a specific detergent releases LDL from the PVS/PEGME complex. The released LDL reacts with the enzymes to produce H2O2 which is quantified by the Trinder reaction.

Here's an analysis of the acceptance criteria and study details for the Diazyme LDL-Cholesterol Reagent, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" as distinct, quantifiable thresholds that the device must meet on its own for approval. Instead, the performance of the Diazyme LDL-Cholesterol Reagent is presented and compared primarily to a legally marketed predicate device (Genzyme N-Geneous LDL Cholesterol Reagent, K971573) to demonstrate substantial equivalence. The implication is that performance comparable to the predicate (and within generally accepted clinical laboratory standards for such assays) constitutes the acceptance.

Therefore, the table below reflects the reported performance of the Diazyme device and, for comparison, the predicate device as presented in the submission. The "acceptance criteria" are inferred as comparable performance to the predicate and generally good laboratory practice for quantitative assays.

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

• Sample Size: The document repeatedly mentions "samples tested with Diazyme LDL-Cholesterol Reagent showed good correlation with Genzyme N-geneous LDL Cholesterol Reagent (K971573) with correlation coefficients of 0.996 for serum samples" and refers to "clinical patient samples." However, the exact number of samples used for the method comparison (test set) is not explicitly stated in the provided text.
• Data Provenance: The text does not specify the country of origin of the data. It is implied that the data is retrospective, as it involves "samples tested" and a comparison was made using these samples. The term "clinical patient samples" also suggests that these were real-world samples collected from patients.

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

This information is not provided in the document. For an in vitro diagnostic reagent like this, the "ground truth" for the test set is established by testing the same samples using a well-established, often reference, method or a legally marketed predicate device. The expertise lies in the laboratory performing the tests and ensuring proper execution, not typically in a panel of experts reviewing the results in the same way as, for example, image-based diagnostics.

In this case, the predicate device (Genzyme N-geneous LDL Cholesterol Reagent) serves as the comparator or "reference" for demonstrating substantial equivalence. The ground truth for the predicate device itself is stated to be traceable to the CDC HDL reference method, which is a highly standardized and rigorous method.

4. Adjudication Method for the Test Set

This is not applicable in the context of this type of quantitative diagnostic assay. Adjudication methods (like 2+1 or 3+1) are typically used in studies involving subjective interpretation, such as image analysis where multiple readers might disagree, and a consensus needs to be formed for the ground truth. Here, the "truth" is a quantitative value obtained from a chemical reaction. The comparison is statistical, between two quantitative results.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices, especially in imaging, where human readers interpret results with and without AI assistance. The Diazyme LDL-Cholesterol Reagent is a laboratory reagent for quantitative chemical analysis, not an AI-assisted diagnostic tool that aids human readers.

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

The entire performance evaluation described for the Diazyme LDL-Cholesterol Reagent is a standalone (algorithm/reagent only) performance. The device is a reagent system that produces a quantitative result. There is no "human-in-the-loop" in the interpretation of the final quantitative value (though humans operate the instruments and handle the samples). The accuracy and precision data presented are reflective of the reagent's performance on its own.

7. The Type of Ground Truth Used

The ground truth used for comparison (and thus, implicitly, for evaluating the Diazyme device) is derived from the results obtained from a legally marketed predicate device (Genzyme N-geneous LDL Cholesterol Reagent, K971573). The submission states: "Genzyme N-geneous LDL Cholesterol Reagent (K971573) was selected for comparing serum samples with to the results generated by Diazyme LDL-Cholesterol Reagent." The predicate device itself traces its calibrator to the NIST SRM 1915b and its method to the CDC HDL reference method, indicating a robust underlying ground truth reference.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided in the document. The Diazyme LDL-Cholesterol Reagent is a chemical reagent assay, not an AI/machine learning model that requires a "training set." Its operating parameters (e.g., reagent concentrations, reaction times) would be optimized during its development process, but this is a different concept from training an algorithm.

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

This information is not applicable as there is no "training set" in the context of this chemical reagent device.

Ask a specific question about this device

HbA1C Enzymatic Assay is intended for the in vitro quantitative determination of stable HbA1c (glycated hemoglobin A1c; A1c) in human whole blood samples. Measurement of hemoglobin A1C is a valuable indicator for long-term diabetic control.

The Diazyme's HbA1C assay kit is a clinical test kit, intended for quantitative determination of HbA1C to monitor long-term glucose control in individuals with diabetes mellitus. The Diazyme's HbA1C assay kit is comprised of a Reagent 1, Reagent 2, Lysis Buffer, THb Reagent, and calibrators. Measurement of hemoglobin A1C is determined enzymaticly by subjecting lyseted samples to extensive protease digestion. This process releases amino acids including glycated valines from the hemoglobin octa peptide. Fructosyl valine oxidase (FVO) then serves as a substrate for fructosyl valine oxidase (FVO) which releases N-terminal valines and produces hydrogen peroxide. The hydrogen peroxide is measured using a peroxidase catalyzed reaction. Total hemoglobin is determined separately by conversion of all hemoglobin derivatives of the samples into hematin using an alkaline method. HbA1C concentration is expressed as a concentration ratio of glycated hemoglobin to total hemoglobin.

The provided text describes the Diazyme HbA1C Enzymatic Assay. Here's an analysis of its acceptance criteria and the study proving it meets those criteria:

1. Table of Acceptance Criteria and the Reported Device Performance:

Study that Proves the Device Meets Acceptance Criteria:

The study presented to prove the device meets the acceptance criteria is a comparison study against a legally marketed predicate device (Tosoh Medics, Inc. Automated HPLC Analyzer: HbA1c Variant Analysis Mode, K011434), along with internal performance evaluations for precision and interference.

• Comparison Study: Diazyme's HbA1C Enzymatic Assay showed a correlation coefficient of 0.92 with the predicate device. This high correlation is presented as evidence of substantial equivalence.
• Precision (Reproducibility) Study: Both Intra-Assay and Inter-Assay precision were evaluated at two HbA1c levels (5.3% and 12%). The CV% values are reported as shown in the table above.
• Interference Study: The assay was tested for interference from common substances (Triglyceride, Bilirubin, Ascorbic Acid, Uric Acid, Glucose) at clinically relevant concentrations. No significant interference was found.

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

• Sample Size for Test Set: The document mentions "actively testing clinical patient samples" for the comparison study, but does not specify the exact number of samples used for the correlation study or the precision/interference studies.
• Data Provenance: Not explicitly stated, but the mention of "clinical patient samples" implies retrospective or prospective clinical samples. The country of origin is not provided.

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

This information is not provided in the document. For an HbA1C assay, the "ground truth" for the comparison study would typically be the results generated by the predicate device and for internal studies, carefully prepared reference materials or controls. The document does not describe an expert panel establishing ground truth in the way it might for an imaging AI device.

4. Adjudication method for the test set:

Not applicable in the context of an HbA1C enzymatic assay. Adjudication methods like 2+1 or 3+1 are typically used for subjective clinical assessments where multiple experts independently rate cases, and discrepancies are resolved. For a quantitative assay like this, the "ground truth" is established by the reference method (predicate device) and analytical measurements.

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:

Not applicable. This is an in vitro diagnostic device for quantitative determination of HbA1C, not an AI-assisted diagnostic imaging or classification tool that would involve human readers.

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

Yes, the device is inherently a standalone (algorithm/assay only) system. Its performance is evaluated purely on its analytical capabilities (precision, accuracy, correlation to a reference method, interference). It does not involve human interpretation in its primary function.

7. The type of ground truth used:

• For the comparison study, the results from the predicate device (Tosoh Medics, Inc. Automated HPLC Analyzer: HbA1c Variant Analysis Mode) served as the ground truth/reference method.
• For precision studies, presumably calibrated control materials with known HbA1C concentrations were used.
• For interference studies, spiked control materials with known concentrations of interfering substances were used.

8. The sample size for the training set:

Not applicable. This is a traditional in vitro diagnostic (IVD) assay based on enzymatic reactions, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The development of the assay would involve various R&D experiments, but not a formally defined "training set" like for AI models.

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

Not applicable, as there is no "training set" in the AI/machine learning sense. The ground truth for developing and validating the assay relies on established biochemical principles, analytical chemistry techniques, and comparison to recognized reference methods.

Ask a specific question about this device

Djazyme Enzymatic Homocysteine Assay is intended for the in vitro quantitative determination of total L-homocysteine in serum and heparin plasma. The reagents can assist in diagnosis and treatment of patients suspected in having hyperhomocysteinemia and homocystinuria.

Diazyme Homocysteine Enzymatic Assay Kit contains a single calibrator. The calibrator is used to generate a calibration point that will be used in the calculation of homocysteine concentrations in unknown serum samples.

Diazyme Homocysteine Enzymatic Assay has controls for normal serum homocysteine level and abnormal serum homocysteine level. The controls are used as reference samples for checking the functionality of the Diazyme Homocysteine Enzymatic Assay.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Diazyme Homocysteine Enzymatic Assay Kit. This type of document does not typically contain the detailed study information (acceptance criteria, sample sizes, ground truth establishment, etc.) that would be found in a clinical study report or a more comprehensive submission document.

510(k) clearances establish substantial equivalence to a legally marketed predicate device, and while performance data is submitted, the letter itself is a summary of the FDA's decision, not the full study report.

Therefore,Based on the provided text, it is not possible to extract the requested information regarding acceptance criteria and the study details. The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a predicate device but does not include the detailed performance study methodology, acceptance criteria, or results.

To answer your questions, one would need to refer to the actual 510(k) submission document (Premarket Notification) submitted by Diazyme Laboratories to the FDA, which would contain the study protocols and results used to demonstrate substantial equivalence.

Ask a specific question about this device

Diazyme Lithium Enzymatic Assay Kit is for quantitative in vitro determination of lithium in human serum and plasma. Measurements of lithium are carried out essentially to ensure that proper drug dosage is administered in the treatment of patient suffering from bipolar disorder and to avoid toxicity.

Diazyme's lithium enzymatic assay is a spectrophotometric method, which can be adapted to most automated clinical chemistry analyzers. In Diazyme's lithium enzymatic assay, Lithium is determined spectrophotometrically through a kinetic coupling assay system involving a Diazyme's proprietary phosphatase whose activity is sensitive to lithium concentration (IC50=0.1mM). Through enzymatic coupling, the phosphatase substrate, adenosine biphosphate (PAP) is converted to hypoxanthine by a series of enzymatic reactions to generate uric acid and hydrogen peroxide (H2O2). H2O2 generated reacts with N-Ethyl-N-(2-hydroxy-3-sulfopropyl)-3-m-toluidine (EHSPT) and 4-aminoantipyrine (4-AA) in the presence of peroxidase (POD) to form a quinone dye which has maximal absorbance at 556nm. The rate of the quinine dye formation is inversely proportion to the concentration of lithium in serum samples.

The provided document (K033360) describes the Diazyme Lithium Enzymatic Assay Kit, a device for quantitative in vitro determination of lithium in human serum and plasma. The document is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner as "pass/fail" thresholds. Instead, the document presents performance characteristics and asserts that they demonstrate excellent accuracy and safety/effectiveness. The comparison is primarily against a predicate device and existing methods.

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

• Sample Size: The document mentions "clinical patient serum samples" for the comparison analysis with the predicate device but does not specify the exact number of samples used in the test set.
• Data Provenance: The document does not explicitly state the country of origin. The studies appear to be retrospective as they involve testing existing clinical patient serum samples and comparing them to established methods.

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

This type of information is generally not applicable to an in vitro diagnostic (IVD) assay for a quantitative analyte like lithium. The "ground truth" for lithium concentration would be established by established analytical methods (e.g., ISE, atomic absorption spectrophotometry, predicate device) or reference materials, not by expert consensus on interpretation. Therefore, there were no experts in the sense of clinicians or radiologists used to establish ground truth.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is analytical, not interpretive.

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

Not applicable. This is an in vitro diagnostic assay for quantifying a chemical analyte (lithium), not an imaging device or AI-driven diagnostic that involves human reader interpretation. Therefore, MRMC studies and "human reader improvement with AI" are not relevant to this device.

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

This statement applies to the Diazyme Lithium Enzymatic Assay as it is a standalone assay. It provides a quantitative result for lithium concentration based solely on the enzymatic reaction and spectrophotometric measurement, without human intervention for interpretation beyond standard laboratory procedures (e.g., sample handling, instrument operation). The "algorithm" here is the chemical reaction and measurement protocol that generates the result.

7. The Type of Ground Truth Used

The ground truth was established by:

• Comparison to Legally Marketed Predicate Device: Trace Lithium Reagent (K003583).
• Comparison to Established Analytical Methods: Ion-selective electrode (ISE) method.
• Reference Materials/Spiking Studies: For linearity (implied by "wide measuring range") and interference studies, where samples were spiked with known concentrations of lithium or interfering substances.
• Known Concentrations: For precision studies (1.0mM Li+ and 2.4mM Li+).

8. The Sample Size for the Training Set

The document does not specify a training set size. For an enzymatic assay like this, "training set" is not typically a concept used in the same way as for machine learning algorithms. The assay development would involve optimizing reagents and conditions, which is analogous to "training" but doesn't involve a distinct, quantified "training set" of patient samples in the way an AI model would have.

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

As explained above, a traditional "training set" with established ground truth in the context of an AI/machine learning model is not directly applicable. The "ground truth" for optimizing the assay would come from:

• Chemical principles and known reactions: The design of the enzymatic coupling system.
• Known concentrations of lithium: To establish the dose-response curve and sensitivity.
• Reference materials: For calibration and verification of the assay's performance during development.
• Comparison to existing methods: During the development and optimization phase to ensure the new assay aligns with established ways of measuring lithium.

Ask a specific question about this device