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The Access DHEA-S assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative measurement of dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

Measurement of dehydroepiandrosterone sulfate may be used in the differential diagnosis of Cushing's syndrome as well as in the evaluation of adrenocortical diseases, congenital adrenal hyperplasia, and adrenal tumors. In hirsute female patients, increased DHEA-S levels have been associated with virilizing adrenal tumors. Patients with polycystic ovary syndrome have often demonstrated elevated levels of DHEA-S, with persons overall androgen contribution to the defect in this disorder.

The Access DHEA-S Calibrators are intended to calibrate the Access DHEA-S assay for the quantitative determination of Dehydroepiandrosterone sulfate levels in human serum and plasma using the Access Immunoassay Systems.

The Access® DHEA-S Reagent is designed for optimal performance on the Access family of Immunoassay Systems, including the Access 2, UniCel Dxl and UniCel DxC Systems. The Access Immunoassay Systems utilize a competitive binding immunoassay for quantitative analyte measurement. The Access DHEA-S Reagent is packaged in two 50-test reagent packs and is packaged separately from the associated calibrators. The Access DHEA-S Calibrators are designed for use with the Access DHEA-S Reagent for generation of the Access calibration curve on Access Immunoassay Systems. The Access calibrators are packaged in 5.0 mL bottles, one for each of six calibrator levels.

Here's a breakdown of the acceptance criteria and study information for the Access® DHEA-S Reagent and Calibrators, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state formal "acceptance criteria" with numerical targets for each performance parameter. Instead, it presents performance data and implies that these results were considered sufficient for substantial equivalence. The comparison is made against a legally marketed predicate device (Immulite DHEA-SO4 Reagent).

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

• Sample Size (Method Comparison): 263
• Data Provenance: Not explicitly stated in the summary (e.g., country of origin, retrospective or prospective). It is generally assumed that such studies for 510(k) submissions use prospectively collected samples or well-characterized retrospective samples.
• Sample Size (Imprecision): 80 for each of the 5 levels tested, for both within-run and total imprecision. The "N" column likely refers to the number of replicates or measurements performed for each level.

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

This information is not applicable to this type of device (in vitro diagnostic for quantitative analyte measurement). The "ground truth" for chemical assays like this is typically established by reference methods or validated laboratory measurements, not by expert consensus or review of images.

4. Adjudication Method for the Test Set

This information is not applicable for this type of device. Adjudication methods (like 2+1, 3+1) are typically used in studies involving subjective interpretation, such as imaging studies, to resolve discrepancies between readers. This device measures a quantitative biochemical marker.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable to this device. This is an in vitro diagnostic assay, not an AI-based interpretation tool for human readers. Therefore, there are no "human readers" to improve with AI assistance in the context of this submission.

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

This information is not applicable in the AI sense. The device itself is a standalone assay system (reagent and calibrators used with an automated analyzer). Its performance is evaluated independently of human interpretation, but it's not an "algorithm" in the modern AI sense.

7. The Type of Ground Truth Used

For method comparison, the "ground truth" or reference values were generated by the predicate device (Immulite DHEA-SO4 Assay). For imprecision, the "ground truth" is derived from statistical analysis of repeated measurements of known concentration levels. It is based on analytical measurements of DHEA-S levels.

8. The Sample Size for the Training Set

The 510(k) summary does not specify a separate "training set" sample size. For an IVD like this, validation studies typically involve a single test set to demonstrate performance characteristics such as method comparison, linearity, and imprecision. While reagent formulation and assay development would involve internal optimization, it is not referred to as a "training set" in the context of this regulatory submission, nor are its details typically provided for the public summary.

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

Since a "training set" is not explicitly mentioned or relevant in the context of this 510(k) summary for an IVD, the ground truth establishment for it is not described. For the performance evaluation that is reported, the ground truth is established by either the predicate device (for method comparison) or by repeated measurements of known samples (for imprecision).

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The IBL DHEA-S ELISA test kit is intended for the in vitro determination of DHEA-S (dehydroepiandrosterone sulphate) in human serum and plasma. DHEA measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to KMI Diagnostics, Inc. regarding their IBL DHEA-S ELISA Test Kit. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about:

• Acceptance criteria for device performance.
• The study design or results that prove the device meets acceptance criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• How ground truth was established for the training set.

The document is purely a regulatory letter stating that the device is cleared for marketing based on substantial equivalence, not a summary of a performance study.

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The DSL C2700 DHEA-S-7 RIA assay is intended for the quantitative determination of DHEA-S in human serum. The measurement of DHEA-S is used for in vitro diagnostic use in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

The DSL C2700 DHEA-S-7 RIA kit was developed for the quantitative measurement of DHEA-S in human serum. The RIA format is a competitive binding protein assay. Radio-labeled DHEA-S competes with un-labeled DHEA-S in the serum sample for binding sites to the DHEA-S antiserum provided with the kit. Separation of free from bound DHEA-S is achieved by the centrifugation and decantation of the tubes. The resultant is analyzed in a gamma counter for bound counts per minute. The amount of radio-labeled DHEA-S bound to the antibody is inversely proportional to the concentration of the DHEA-S present in the sample.

1. Table of Acceptance Criteria and Reported Device Performance:

   Performance Metric	Acceptance Criteria	Reported Device Performance (DSL C2700 DHEA-S-7 RIA kit vs. DSL 2700 DHEA-S RIA)
   Correlation (r)	Implied satisfactory correlation between the two assays to demonstrate substantial equivalence.	r = 0.98
   Linear Regression	Implied satisfactory linear relationship between the two assays to demonstrate substantial equivalence.	Y = 0.76(X) + 36.2 (where Y is the DSL C2700 DHEA-S-7 RIA kit result and X is the DSL 2700 DHEA-S RIA result). This indicates a strong linear relationship.

   Note: The document does not explicitly state numerical acceptance criteria for 'r' or the linear regression equation. The reported performance implies that these results were considered acceptable for demonstrating substantial equivalence.

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

   • Sample Size: 418 patient samples.
   • Data Provenance: Not explicitly stated, but based on the overall context of a medical device submission in the USA, it is likely that the samples were collected in the USA. The study design appears to be retrospective or a cross-sectional comparison using pre-collected samples.

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

   • This section is not applicable as the study described is a comparison of two assays for quantitative measurement, not a ground truth establishment by human experts for diagnostic imaging or similar tasks. The "ground truth" in this context is the result obtained from the predicate device (DSL 2700 DHEA-S RIA).

4. Adjudication Method for the Test Set:

   • This section is not applicable. The study involves quantitative measurements from two different assays, not subjective interpretations requiring adjudication.

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

   • No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This study compared two immunoassay kits, not human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

   • Yes, a standalone performance evaluation was conducted. The DSL C2700 DHEA-S-7 RIA kit's performance was directly compared against the predicate device (DSL 2700 DHEA-S RIA) by running the same patient samples on both kits independently to assess their agreement and correlation. There is no human-in-the-loop component described for the measurement itself.

7. Type of Ground Truth Used:

   • The "ground truth" in this context is the quantitative measurement of DHEA-S levels obtained from the predicate device, the DSL 2700 DHEA-S RIA kit. The study aimed to demonstrate substantial equivalence to an already approved and established method.

8. Sample Size for the Training Set:

   • This information is not provided in the summary. The document describes a comparison study for substantial equivalence, not the development or training of a de novo algorithm.

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

   • This information is not provided as the document does not describe the development or training phase for a new algorithm, but rather a comparative study for a new iteration of an existing assay against a predicate.

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