DSL DHEA-S-7

• K Number: K962895
• Device Name: DSL DHEA-S-7
• Manufacturer: DIAGNOSTIC SYSTEMS LABORATORIES, INC.
• Date Cleared: 1996-09-10 ( 47 days)
• Product Code: JKC
• Regulation Number: 862.1245
• Type: Traditional
• Panel: CH
• Reference & Predicate Devices: N/A

Intended Use

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.

Device Description

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.

AI/ML Overview

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.

Regulation Number and Section

§ 862.1245 Dehydroepiandrosterone (free and sulfate) test system.

(a)
Identification. A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.