(48 days)
The DSL-10-3200 T4 Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of T4 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid disease.
The DSL ACTIVE™ T4 EIA kit was developed for the quantitative measurement of T4 in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled T4 competes with un-labeled T4 in the serum sample for binding sites with the Anti-T4 antibody in microtitration wells. Separation of free from bound T4 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 T4 bound to the antibody is inversely proportional to tne concentration of the T4 present in the sample.
The provided text describes a 510(k) submission for the "DSL ACTIVE™ T4 EIA Kit" and its substantial equivalence to a predicate device, the "DSL ACTIVE™ T4 RIA." The study focuses on demonstrating this equivalence rather than establishing acceptance criteria and testing against them in the traditional sense of a clinical trial for a novel device.
However, we can extract the relevant information regarding the performance comparison to demonstrate substantial equivalence, which serves as a form of "acceptance criteria" for regulatory purposes in this context.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" revolve around showing comparable performance to a legally marketed predicate device. In this case, the key metric is the correlation between the new device and the predicate.
| Acceptance Criteria | Reported Device Performance (DSL ACTIVE™ T4 EIA Kit vs. DSL ACTIVE™ T4 RIA) |
|---|---|
| Strong linear correlation with predicate device | Linear regression equation: Y = 0.72(X) - 0.24 |
| Correlation coefficient (r): 0.96 | |
| (Indicating a strong positive linear relationship) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 59 patient samples (n=59)
- Data Provenance: The document does not explicitly state the country of origin. It mentions "patient samples were collected." It is a retrospective comparison, as the samples were collected and then assayed using both methods for comparison.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study does not involve "experts establishing ground truth" in the way a diagnostic imaging study might. Instead, the predicate device (DSL ACTIVE™ T4 RIA) itself served as the reference standard against which the new device's performance was compared. The "ground truth" for the T4 levels in the samples was established by the predicate device's readings. No human experts were involved in establishing the T4 values for comparison in this regulatory context.
4. Adjudication Method for the Test Set
No adjudication method was used for the test set. The study directly compared the measurements obtained from the new device with those from the predicate device through linear regression.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This study is an in-vitro diagnostic device comparison, not a human reader performance study. Therefore, an MRMC study and effect size for human readers are not applicable.
6. Standalone Performance (Algorithm only without human-in-the-loop performance)
Yes, in essence, this is a standalone performance study of the DSL ACTIVE™ T4 EIA Kit. The kit (an enzyme immunoassay) is an automated or semi-automated system that provides a quantitative measurement. The performance being evaluated is the kit's ability to measure T4 levels compared to the predicate device, not its interaction with a human operator for interpretation.
7. Type of Ground Truth Used
The "ground truth" for the T4 levels in the patient samples was established by the predicate device, the DSL ACTIVE™ T4 RIA. This is a common approach in 510(k) submissions where a new device is compared to a legally marketed device as a reference.
8. Sample Size for the Training Set
The document does not mention a separate "training set" or "training data" size. This type of submission, focused on demonstrating substantial equivalence, typically relies on a comparison study with a predicate device. The DSL ACTIVE™ T4 EIA kit was "developed" for T4 measurement, implying internal optimization, but details about training data used in its development are not provided in this regulatory summary.
9. How the Ground Truth for the Training Set Was Established
Given that no explicit training set or its size is provided, the method for establishing its ground truth is also not mentioned. Immunoassay development involves calibrators and controls, but these are part of the assay's design and validation rather than a "ground truth" for a machine learning model's training set as might be seen in AI device development.
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MAY 22 1997
445 Wellington Street
Leicester LE45 5BA
Tel: 23 55 44
Fax: 25 44 55
Customer Assistance
Tel: 8002 22 00
Fax: 2813 33 95
Email: mrg@d.co
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 10-3200 ACTIVE™ T4 EIA Kit Name of Device: Enzymeimmunoassay, T4 Classification Name: Analyte Code and Name: T4 Requlatory 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™ T4 EIA kit was developed for the quantitative measurement of T4 in human serum. The EIA format is a competitive binding protein assay. Enzyme-labeled T4 competes with un-labeled T4 in the serum sample for binding sites with the Anti-T4 antibody in microtitration wells. Separation of free from bound T4 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 T4 bound to the antibody is inversely proportional to tne concentration of the T4 present in the sample.
The DSL ACTIVE™ T4 EIA assay is intended for the quantitative determination of T4 in human serum. The measurement of T4 is used in the diagnosis and treatment of thyroid disease.
The DSL ACTIVE™ T4 EIA is substantially equivalent to the DSL ACTIVE™ T4 RIA.
To demonstrate substantial equivalence between the two assays, patient samples (n = 59) were collected and assayed using both methods. Samples were chosen based on expected T4 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 =0.72(X) -0.24 with a correlation coefficient of (r) = 0.96.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 22 1997
John Willis Director of Requlatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard
Webster, Texas 77598
Re : K971269 DSL 10-3200 ACTIVE™ T4 EIA Kit Requlatory Class: II KLI Product Code: Dated: April 3, 1997
Received: April 4, 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 regulatory 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 requlation (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 Gutman
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: Thyroxine (T4) EIA
Indications For Use: "
The DSL-10-3200 T4 Enzymeimmunoassay (EIA) Kit provides materials for the quantitative measurement of T4 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid disease.
IPLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Div. | |
| Div. | ices |
| 510(k) Numbe | K971269 |
Prescription Use
(Per 21 CFR 801.109)
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Over-The-Counter Use_
§ 862.1700 Total thyroxine test system.
(a)
Identification. A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.