(31 days)
The DSL-10-4000 ACTIVE™ Testosterone Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of testosterone in serum. This assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycystic ovaries and adrenogenital syndrome.
The EIA format is a competitive binding protein assay. Enzyme-labeled Testosterone competes with un-labeled Testosterone in the serum sample for binding sites with the Anti-Testosterone antibody in microtitration wells. Separation of free from bound Testosterone is achieved by washing and decanting the microtiter plates after incubation. The resultant is analyzed in a spectrophotometer for absorbance. The amount of enzyme-labeled Testosterone bound to the antibody is inversely proportional to the concentration of the Testosterone present in the sample.
The provided document describes the DSL ACTIVE™ Testosterone EIA kit and its substantial equivalence to the DSL Testosterone RIA. There is no information regarding a specific device that uses AI or machine learning, nor any "acceptance criteria" in the sense of performance thresholds that the device must meet to be considered effective, other than demonstrating substantial equivalence to a predicate device.
However, based on the information provided, we can infer how the substantial equivalence was demonstrated, which serves as the "acceptance criteria" for marketing the device.
Here's an analysis based on the provided text, structured to answer your questions where applicable, and noting where information is not available:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The primary "acceptance criteria" for the DSL ACTIVE™ Testosterone EIA kit was to demonstrate substantial equivalence to a legally marketed predicate device, the DSL Testosterone RIA. This was evaluated through a comparison study of human serum samples.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance |
|---|---|
| Method Comparison: Linear regression analysis between the new device (DSL ACTIVE™ Testosterone EIA) and the predicate device (DSL Testosterone RIA) on human serum samples. | Linear Regression Equation: Y = 0.094(X) + 0.1 Correlation Coefficient (r): 0.93 |
| (Implicit) Acceptable correlation (r) and agreement (slope and intercept) indicating similar quantitative results between the two methods. | A high correlation coefficient (0.93) suggests strong agreement. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 150 human serum samples (
n = 150). - Data Provenance:
- Country of Origin: Not explicitly stated. However, given the submitting company's address is in Webster, Texas, USA, and the FDA's jurisdiction, it's highly probable the samples were collected in the United States.
- Retrospective or Prospective: Not explicitly stated. However, the samples were "collected and assayed" for the purpose of the comparison, which could imply a prospective collection, or a retrospective selection from a bank of samples. The crucial point is that they were chosen to represent a range of Testosterone levels ("low, intermediate and high").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This is not applicable in this context. The "ground truth" for this type of in vitro diagnostic device is the measurement itself, and the comparison is against another established, legally marketed assay (the predicate device). There is no mention of experts establishing ground truth in the sense of clinical interpretation or diagnosis. The predicate device's results serve as the reference.
4. Adjudication Method for the Test Set
Not applicable. This was a direct comparison of quantitative measurements from two assays, not an adjudicated review of interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This is an in vitro diagnostic device for quantitative measurement, not an imaging or interpretive device that would involve human readers in the way an MRMC study evaluates. There's no AI component mentioned that would assist human readers.
6. Standalone (Algorithm Only) Performance Study
Yes, in a sense. The "device performance" described (Y = 0.094(X) + 0.1 with r = 0.93) is the standalone performance of the DSL ACTIVE™ Testosterone EIA kit when compared to the DSL Testosterone RIA. The kit operates independently to produce a quantitative result. There is no human-in-the-loop component for the assay's function itself.
7. Type of Ground Truth Used
The "ground truth" was established by the predicate device's measurement results (DSL Testosterone RIA). The new device's measurements were compared against these established measurements. There was no pathology, expert consensus (in the diagnostic sense), or outcomes data used to establish "ground truth" for the individual sample values.
8. Sample Size for the Training Set
No training set is mentioned. This is a traditional immunoassay, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
Summary of Device and Approval:
The DSL 10-4000 ACTIVE™ Testosterone EIA Kit is a competitive binding protein assay designed for the quantitative measurement of Testosterone in human serum. It works by having enzyme-labeled Testosterone compete with un-labeled Testosterone from the sample for binding sites on an Anti-Testosterone antibody. The amount of enzyme-labeled Testosterone bound is inversely proportional to the Testosterone concentration in the sample.
The device was cleared for marketing by the FDA as substantially equivalent to the DSL Testosterone RIA. The demonstration of substantial equivalence was based on a comparison study of 150 human serum samples. Linear regression analysis of the results between the new device (Y) and the predicate device (X) yielded the equation Y = 0.094(X) + 0.1 with a correlation coefficient (r) of 0.93. This high correlation coefficient suggests a strong agreement between the two assays across a range of Testosterone levels (low, intermediate, and high), thereby meeting the implicit acceptance criteria for substantial equivalence.
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Image /page/0/Picture/0 description: The image shows a black and white logo. The logo appears to be a stylized representation of the letters 'd' and 'l' or 'di', with the 'd' on the left and the 'l' on the right. The letters are connected or overlapping, creating a unique and abstract design. The image quality is somewhat degraded, with some pixelation and artifacts visible.
JUN 16 1997
inostic Systems Labora 445 Medical Center Bouley Webster Texas 77598-4217 1 Tel 281 332 9678
Customer Assistance Cente Tel 800.231 7970 Fax 281 338 189 Email mktg(@dslabs.com
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 10-4000 ACTIVE™ Testosterone EIA Kit Name of Device: Classification Name: Enzymeimmunoassay, Testosterone Analyte Code and Name: Testosterone Regulatory Class:
John Willis Submitter : Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone:281-332-9678
May 14, 1997 Date:
The DSL ACTIVE™ Testosterone EIA kit was developed for the quantitative measurement of Testosterone in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled Testosterone competes with un-labeled Testosterone in the serum sample for binding sites with the Anti-Testosterone antibody in microtitration wells. Separation of free from bound Testosterone is achieved by washing and decanting the microtiter plates after incubation. The resultant is analyzed in a spectrophotometer for absorbance. The amount of enzyme-labeled Testosterone bound to the antibody is inversely proportional to the concentration of the Testosterone present in the sample.
The DSL ACTIVE™ Testosterone EIA assay is intended for the quantitative determination of Testosterone in human serum. The measurement of Testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycyctic ovaries and adrenogenital syndromes.
The DSL ACTIVE™ Testosterone EIA is substantially equivalent to the DSL Testosterone RIA.
To demonstrate substantial equivalence between the two assays, human serum samples (n = 150) were collected and assayed using both methods. Samples were chosen based on expected Testosterone levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation Y = 0.0.94(X) + 0.1 with a correlation coefficient of (r) = 0.93.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling an emblem. The emblem is a stylized representation of three intertwined figures, possibly symbolizing people or services, with the words "SERVICES - USA" appearing above the emblem.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN 16 1997
John Willis Director of Requlatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598
Re : K971823 Active Testosterone EIA Requlatory Class: I Product Code: CDZ May 14, 1997 Dated: Received: May 16, 1997
Dear Mr. Willis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
- if you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
sincerely yours,
Steven Litman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: ACTIVE™ .Testosterone EIA .....
Indications For Use:
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The DSL-10-4000 ACTIVE™ Testosterone Enzymeimmunoassay (EIA) Kit provides materials før the quantitative measurement of testosterone in serum. This assay is intended for in vitro diagnostic use. Measurement of testosterone is used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and in females hirsutism and virilization due to tumors, polycystic ovaries and adrenogenital syndrome.
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K971823
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
§ 862.1680 Testosterone test system.
(a)
Identification. A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.(b)
Classification. Class I.