(48 days)
The DSL-10-3100 T3 Enzymeimmunoassay (EIA) Kit provides materials for the guantitative measurement of T3 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
The ElA format is a competitive binding protein assay. Enzyme-labeled T3 competes with un-labeled T3 in the serum sample for binding sites with the Anti-T3 antibody in microtitration wells. Separation of free from bound T3 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 T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample.
The provided document describes the substantial equivalence of the DSL ACTIVE™ T3 EIA Kit to the DSL ACTIVE™ T3 RIA, not the acceptance criteria and study for a new device or algorithm in the way typically expected for AI/ML medical devices. The submission is for a traditional in-vitro diagnostic (IVD) kit.
Therefore, many of the requested categories are not directly applicable or are interpreted within the context of an IVD comparison rather than an AI/ML device study.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criterion for substantial equivalence in this context is based on a statistical comparison (linear regression and correlation coefficient) between the new device (DSL ACTIVE™ T3 EIA) and a legally marketed predicate device (DSL ACTIVE™ T3 RIA).
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Linear correlation coefficient (r) between predicate and new device | r = 0.97 | This value indicates a strong positive linear relationship between the results of the two assays. |
| Regression equation | Y = 1.08(X) - 6.0 | This equation describes the relationship between the new device (Y) and the predicate device (X). An ideal relationship would be Y = X or Y = 1(X) + 0. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: n = 68 patient samples.
- Data Provenance: The document does not specify the country of origin. Samples were "chosen based on expected T3 levels so that samples with low, intermediate and high levels would be evaluated," indicating a strategic selection to cover the dynamic range of the assay. The study is implicitly retrospective as patient samples were "collected and assayed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not applicable in the context of this submission. The "ground truth" for evaluating the new assay is the performance of the legally marketed predicate device (DSL ACTIVE™ T3 RIA) itself. The comparison is between two quantitative assays measuring the same analyte, not an expert-derived truth.
4. Adjudication Method for the Test Set
Not applicable. This is a quantitative comparison of two assays. There is no qualitative assessment or expert adjudication involved in generating the reference values or evaluating the results of the new device; raw numerical data from the predicate device serves as the reference.
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
Not applicable. This is not an AI/ML device or a diagnostic imaging device requiring human reader interpretation, hence no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a laboratory immunoassay kit. Its performance is inherent to the kit's reagents and methodology, not an algorithm's standalone performance. The results are read by a spectrophotometer, which is a standard lab instrument.
7. The Type of Ground Truth Used
The "ground truth" for the performance evaluation of the DSL ACTIVE™ T3 EIA Kit was the quantitative measurement of T3 in human serum obtained from the predicate device, the DSL ACTIVE™ T3 RIA. This is a "comparative ground truth" against an existing, legally marketed device of the same type, rather than pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
Not applicable in the AI/ML sense. This device is a biochemical measurement kit. It does not involve a "training set" for model development. The development of the kit (e.g., reagent formulation, antibody selection) is not described in terms of machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no "training set" in the context of an AI/ML model for this type of device, this question is not relevant.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows a stylized logo or symbol in black. It appears to be a combination of the letters 'd' and 'a' or a similar abstract design. The 'd' is formed by a vertical line with a curved shape attached to its right side, while the 'a' is represented by a curved line that connects to the 'd' and extends to the right. The overall design is bold and modern.
6971270
MAY 22 1997
Fax 22 : 5 =
Customer Ass Tel 800 23 Fox 28' 338 100 Email mktg dsich:
SUMMARY OF SAFETY AND EFFECTIVENESS
DSL 10-3100 ACTIVE™ T3 EIA Kit Name of Device: Enzymeimmunoassay, T3 Classification Name: Analyte Code and Name: T3 Regulatory Class: 11
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™ T3 EIA kit was developed for the quantitative measurement of T3 in human serum. The ElA format is a competitive binding protein assay. Enzyme-labeled T3 competes with un-labeled T3 in the serum sample for binding sites with the Anti-T3 antibody in microtitration wells. Separation of free from bound T3 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 T3 bound to the antibody is inversely proportional to the concentration of the T3 present in the sample.
The DSL ACTIVE™ T3 EIA assay is intended for the quantitative determination of T3 in human serum. The measurement of T3 is used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
The DSL ACTIVE™ T3 EIA is substantially equivalent to the DSL ACTIVE™ T3 RIA.
To demonstrate substantial equivalence between the two assays, patient samples In = 68) were collected and assayed using both methods. Samples were chosen based on expected T3 levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the companison gave the equation Y = 1.08(X) -6.0 with a correlation coefficient of (r) = 0.97.
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, with three curved lines forming the body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 2 2 1997
John Willis Director of Regulatory Affairs Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598
K971270 Re : DSL 10-3100 ACTIVE™ T3 EIA Kit Requlatory Class: II Product Code: CDP 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, qood 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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requiation (21 CFR Part 620) 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.
{2}------------------------------------------------
Page 2
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
{3}------------------------------------------------
510(k) Number (if known):
Device Name: Triiodothyronine (T3) EIA .. . .
Indications For Use:
The DSL-10-3100 T3 Enzymeimmunoassay (EIA) Kit provides materials for the guantitative measurement of T3 in serum. This assay is intended for in vitro diagnostic use in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.
vision Sign-Off)
ion of Clinical Laboratory Devices
(Division Si
Division of Cical Laboratory
S10(k) Number 570-99
(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
§ 862.1710 Total triiodothyronine test system.
(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.