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

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This document is an FDA 510(k) clearance letter for the Diazyme Colorimetric Lithium Assay. It formally grants permission to market the device based on a determination of substantial equivalence to predicate devices. However, this document does not contain the detailed study information regarding acceptance criteria and performance data.

The letter primarily covers:

• Confirmation of 510(k) review and clearance.
• The trade/device name, regulation number/name, regulatory class, and product code.
• General controls and additional regulations applicable to the device (e.g., Quality System regulation, UDI rule, MDR).
• Contact information for FDA resources.
• The "Indications for Use" statement for the device.

To answer your specific questions, one would typically need access to the 510(k) submission document itself, specifically the performance data sections. The provided FDA letter is the clearance notice, not the supporting technical file.

Therefore, I cannot provide the information requested in your prompt based solely on the provided FDA clearance letter. The letter confirms that a review was done and clearance granted, implying that the device did meet acceptance criteria demonstrated in the submission, but it does not detail those criteria or the study results.

To answer your questions, I would need a different document, such as the actual 510(k) application's test report or a summary of safety and effectiveness data (SSE) that outlines the performance studies.

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The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

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I'm sorry, but the provided text does not contain the information requested in your prompt regarding acceptance criteria and a study proving device performance for an AI/ML medical device.

The document is an FDA 510(k) clearance letter for Diazyme Laboratories Inc.'s Human Kappa Free Light Chain Assay and Human Lambda Free Light Chain Assay. These are in-vitro diagnostic assays (laboratory tests), not AI/ML-based devices. The document primarily discusses:

• The FDA's review and determination of substantial equivalence for these specific assays.
• General regulatory requirements for medical devices (e.g., registration, labeling, good manufacturing practices).
• Indications for use for each assay (quantitative determination of Kappa/Lambda FLC concentrations in serum to aid in diagnosis and monitoring of multiple myeloma).

Therefore, I cannot extract the following information because it is not present in the provided text:

1. A table of acceptance criteria and reported device performance (for an AI/ML device): The document does not describe performance metrics like sensitivity, specificity, AUC, etc., in the context of an AI/ML model for image or other data interpretation.
2. Sample size used for the test set and data provenance: No mention of test sets for an AI/ML model.
3. Number of experts used to establish ground truth and qualifications: This is irrelevant for a chemical assay.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable as there is no AI assistance to human readers.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for chemical assays is typically established through reference methods and clinical correlations, not "expert consensus" in the way it's used for AI image analysis.
8. Sample size for the training set: Not applicable for an IVD assay.
9. How ground truth for the training set was established: Not applicable.

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The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis and monitoring of multiple myeloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on validated analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis and monitoring of multiple mycloma in conjunction with other laboratory and clinical findings. For in-vitro diagnostic use only.

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This document is an FDA 510(k) clearance letter for Diazyme Human Kappa Free Light Chain Assay and Diazyme Human Lambda Free Light Chain Assay. It describes the indications for use of the devices but does not contain any information regarding the acceptance criteria or a study proving the device meets the acceptance criteria.

Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a different document, such as a summary of safety and effectiveness data, a clinical study report, or a 510(k) summary that details the performance studies and acceptance criteria for these specific diagnostic assays.

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Diazyme DZ-Lite iFlash Total BhCG Assay is a chemiluminescent immunoassay intended for use for the quantitative determination of total beta-human chorionic gonadotro pin (total BhCG) in human serum on DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer. The assay is intended for use as an aid in the early detection of pregnancy. Diazyme DZ-Lite iFlash 1800 Chemiluminiscence Immunoassay Analyzer is used clinically in combination with the supporting chemiluminescence immunoassay reagents for determination of analytes in human body fluids through acridinium ester-based chemiluminescence method.

Diazyme DZ-Lite iFlash Total BhCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

This particular document (K212221) is an FDA 510(k) clearance letter, which formally states that the Diazyme DZ-Lite iFlash Total BhCG Assay and Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer are "substantially equivalent" to legally marketed predicate devices.

This document itself does NOT contain the detailed study information (acceptance criteria, test results, sample sizes, ground truth establishment, etc.) that you are asking for.

Typically, this detailed information would be found in the 510(k) summary document submitted by the manufacturer to the FDA, or in the underlying scientific reports and validation studies that formed the basis for the 510(k) submission. The clearance letter only refers to the submission and acknowledges its review.

Therefore, I cannot provide the specific answers to your detailed questions based solely on the provided text. To answer your questions, I would need access to the full 510(k) submission documents, particularly the "510(k) Summary" and potentially the "Device Description" and "Performance Data" sections.

If you had the 510(k) summary, here's how I would typically extract and present the information you requested (using placeholder text where the information is missing from the current document):

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: [e.g., X number of clinical serum samples; Y number of spiked samples]
• Data Provenance: [e.g., Retrospective clinical samples collected from hospitals in the United States and Europe; Spiked samples prepared in-house; Prospective clinical samples from a multi-center study in [Country/Region]]

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

• Number of Experts: N/A (For an immunoassay like BhCG, "ground truth" is typically established by reference methods or validated laboratory methods, not expert consensus in the diagnostic imaging sense).
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication Method: N/A (Ground truth for immunoassay is typically based on a gold standard measurement method, not human adjudication of interpretations).

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

• MRMC Study: No. This device is an in vitro diagnostic (IVD) immunoassay, not an imaging AI device that assists human readers. Therefore, an MRMC study is not applicable.

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

• Standalone Performance: Yes. The performance data presented (e.g., accuracy, precision, LoD, linearity) is the standalone performance of the Diazyme DZ-Lite iFlash Total BhCG Assay on the Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer. The device is designed to provide a quantitative result directly.

7. The type of ground truth used

• Type of Ground Truth: For the Diazyme DZ-Lite iFlash Total BhCG Assay, the "ground truth" is established through:
  • Reference Methods: Comparison of results with a legally marketed predicate device or a clinical laboratory gold standard method (e.g., another highly accurate BhCG assay, often traceably calibrated to the 1st IRP WHO standard).
  • External Quality Control Materials: Samples with known concentrations.
  • Spiked Samples: Negative samples to which known concentrations of BhCG are added.
  • Patient Samples: Clinical samples from various populations (pregnant, non-pregnant, specific medical conditions) with BhCG levels confirmed by reference methods.

8. The sample size for the training set

• Training Set Sample Size: This is generally not applicable in the same way it is for AI/machine learning algorithms. For IVD devices, the development involves optimizing reagents and assay parameters through extensive R&D, rather than "training" an algorithm on a distinct dataset. The "training" would be part of the assay development and optimization process, not a separate, quantified "training set."

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

• Ground Truth for Training Set: N/A (See #8 above). The assay development aims to accurately measure BhCG, and the establishment of its accuracy and other performance characteristics relies on the scientific principles of immunoassay and validation against reference materials and methods.

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The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events.

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The provided text is a 510(k) clearance letter for a medical device, the Diazyme PLAC® Test for Lp-PLA2 Activity. It largely focuses on regulatory aspects and the indication for use, not detailed study data or acceptance criteria. Therefore, I cannot extract the information required to populate all sections of your request from the provided text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets.
• Data provenance (country, retrospective/prospective).
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Information on MRMC studies or effect sizes.
• Standalone performance information.
• Type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

The only relevant information I can derive is the device name and its intended use:

Device Name: Diazyme PLAC® Test for Lp-PLA2 Activity

Indication for Use: "The Diazyme PLAC® Test for Lp-PLA2 Activity is an enzyme assay for the in vitro quantitative determination of Lp-PLA2 (lipoprotein-associated phospholipase A2) activity in EDTA plasma and serum on automated clinical chemistry analyzers. Lp-PLA2 activity is to be used in conjunction with clinical evaluation and patient risk assessment as an aid in predicting risk of coronary heart disease (CHD) in patients with no prior history of cardiovascular events."

To fulfill your request for detailed acceptance criteria and study information, you would need access to the full 510(k) summary or the premarket submission itself, as this letter is merely the FDA's clearance notification.

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Diazyme 1,5-anhydroglucitol (1,5-AG) Assay is an enzymatic method intended for the quantitative determination of 1,5anhydroglucitol (1,5-AG) in serum or plasma. The 1,5-AG Assay is for the intermediate term (preceding 1-2 weeks) monitoring of glycemic control in people with diabetes. For in vitro diagnostic use only.

Diazyme's 1.5-AG assay is an enzymatic method intended for the quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma. The assay uses the enzyme pyranose oxidase (PROD) to oxidize the 2nd position hydroxyl group of 1,5-AG and to detect the generated hydrogen peroxide by colorimetry using peroxidase (POD). To eliminate reactive glucose in sample, it is pretreated by enzymatic reactions using hexokinase and pyruvate kinase (PK). Hexokinase uses adenosine triphosphate (ATP) to convert glucose into non-reactive glucose-6-phosphate (G-6-P), generating adenosine diphosphate (ADP). The reaction is driven to completion with PK, as ADP is phosphoralated to ATP during the conversion of phosphoenolpyruvate (PEP) into pyruvate.

The provided document is a 510(k) premarket notification for the Diazyme 1,5-AG Assay, a device for in vitro quantitative determination of 1,5-anhydroglucitol (1,5-AG) in serum or plasma to monitor glycemic control in people with diabetes.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

• This submission focuses on substantial equivalence to a predicate device (GlycoMark™ 1,5-anhydroglucitol (1,5-AG) K031604) rather than a novel, de novo AI/ML device. Therefore, many standard AI/ML specific criteria like MRMC studies, human-in-the-loop performance, and expert consensus for ground truth are not applicable or detailed in this context.
• The studies presented are primarily analytical performance studies to demonstrate that the new device performs comparably to the predicate device and meets established laboratory testing standards.

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines acceptance by comparing the Diazyme 1,5-AG Assay's performance to the predicate device and established CLSI (Clinical and Laboratory Standards Institute) guidelines for analytical validation.

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

• Precision Study: Six serum samples (tested repeatedly over 240 measurements for each sample to calculate different CV% components).
• Linearity Study: Samples encompassing a wide range of 1,5-AG concentrations (Level 0 to Level 10), tested in triplicate for each level. The exact number of distinct patient samples is not specified, but it implies a spiked matrix or dilutions of real samples.
• Method Comparison (Accuracy) Study: 102 patient samples covering the Analytical Measurement Range (AMR).
• Reference Range Study: 140 apparently healthy males and 140 apparently healthy females (Total 280 samples).
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. It refers to "clinical patient samples" for the method comparison study and "apparently healthy males and females" for the reference range study, implying real human samples. Given the nature of in vitro diagnostic device validation, these are typically prospective collection campaigns or use of well-characterized biobank samples.

3. 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 for quantitative measurement of a biomarker, not an AI/ML device interpreting medical images or other complex data. Therefore, the concept of "experts establishing ground truth" in the same way as, for example, radiologists marking tumors, is not applicable.
• The "ground truth" for the test set is established by the measurement results obtained from the predicate device (GlycoMark™ 1,5-AG assay) for the method comparison study, and by the inherent concentration values of the samples used in precision, linearity, LoB/LoD/LoQ, and interference studies. These are not dependent on expert visual review or interpretation.
• The predicate device itself was validated and approved by the FDA based on its own clinical and analytical performance.

4. Adjudication Method for the Test Set:

• Not applicable in this context. Adjudication methods like 2+1 or 3+1 are used when human experts disagree on interpretations (e.g., in radiology image reading). For quantitative in vitro diagnostic assays, the "truth" is the measured value, and deviations are assessed statistically (e.g., bias, correlation, CV%).

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, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device measuring a chemical biomarker, not an AI system assisting human readers of medical images or other data. The performance is assessed analytically against a predicate device and established laboratory standards.

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

• Yes, in essence, the Diazyme 1,5-AG Assay is a standalone device. It performs the quantitative measurement of 1,5-AG in a sample without direct human interpretation of its internal "algorithm" or sensing process for each test. The results are provided as a numeric value. Humans (lab technicians, clinicians) then interpret these numeric results in the clinical context, similar to any lab test. The performance studies (precision, linearity, method comparison, etc.) directly evaluate the performance of this "standalone" assay.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

• Analytical Reference Values / Predicate Device Measurements:
  • For the method comparison study (accuracy), the "ground truth" was the measurements obtained from the legally marketed predicate device (GlycoMark™ 1,5-AG).
  • For linearity, LoB/LoD/LoQ, and precision studies, the "ground truth" refers to the expected or true concentrations of the analytes in the reference materials or spiked samples. These values are typically established through highly accurate reference methods or certified reference materials traceable to international standards (though not explicitly detailed, this is standard practice for IVD validation).

8. The Sample Size for the Training Set:

• Not applicable in the typical AI/ML sense. This is a chemical assay, not a machine learning algorithm that learns from training data. The "training" for such a device involves optimizing reagents and reaction conditions during development, but there isn't a "training set" of patient data in the same way an AI model is trained.

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

• Not applicable. As explained above, this device does not have a "training set" in the context of AI/ML. The "ground truth" for the analytical studies are the established reference values or predicate device measurements.

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The Diazyme Human Kappa Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Kappa Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Kappa FLC in conjunction with Lambda FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only.

The Diazyme Human Lambda Free Light Chain Assay is intended as a latex particle enhanced immunoturbidimetric assay for the quantitative determination of Lambda Free Light Chain (FLC) concentration in serum on Hitachi 917 analyzers. The measurement of Lambda FLC in conjunction with Kappa FLC aids in the diagnosis of multiple myeloma in conjunction with other laboratory findings. For in-vitro diagnostic use only.

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I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the Diazyme Human Kappa Free Light Chain Assay and Diazyme Human Lambda Free Light Chain Assay. It states the intent to market the device and declares it substantially equivalent to legally marketed predicate devices.

While it mentions the intended use of the assays (quantitative determination of Kappa/Lambda FLC in serum to aid in the diagnosis of multiple myeloma), it does not provide details on:

• Specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity thresholds).
• A study design, methodology, or results demonstrating device performance against such criteria.
• Information regarding sample sizes, data provenance, expert qualifications, ground truth establishment, or clinical study details.

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

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

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This document is a 510(k) premarket notification acceptance letter from the FDA for a device called "Diazyme Lipoprotein (a) Assay." It is an in vitro diagnostic device, not an AI/ML medical device. Therefore, the information required to answer your specific questions about acceptance criteria, study design (sample size, data provenance, expert adjudication, MRMC, standalone performance), and ground truth establishment, which are typical for AI/ML device submissions, is not present in this document.

The document focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• Regulatory classifications and general controls (e.g., annual registration, GMP, labeling).
• Indications for Use for the Diazyme Lipoprotein (a) Assay, which is for the in vitro quantitative determination of lipoprotein(a) [Lp(a)] concentration in human serum.

To answer your questions, I would need a different type of document, such as a clinical study report or a detailed premarket submission summary (e.g., from the FDA's 510(k) database if it provided more detail than this letter).

Therefore, I cannot populate the table or answer the specific questions about the study design, ground truth, and expert involvement based on the provided text.

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