DSL ACTIVE T3 EIA

K971270 · Diagnostic Systems Laboratories, Inc. · CDP · May 22, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971270
• Device Name: DSL ACTIVE T3 EIA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: CDP · Clinical Chemistry
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1710
• Device Class: Class 2

Intended Use

The DSL-10-3100 T3 Enzymeimmunoassay (EIA) Kit provides materials for the quantitative 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.

Device Story

The DSL 10-3100 ACTIVE™ T3 EIA kit is an in vitro diagnostic assay for quantitative T3 measurement in human serum. It utilizes a competitive binding protein assay format. Enzyme-labeled T3 and unlabeled T3 from the patient sample compete for binding sites on Anti-T3 antibodies immobilized in microtitration wells. Following incubation, plates are washed and decanted to separate bound from free T3. The amount of bound enzyme-labeled T3 is measured via spectrophotometry; absorbance is inversely proportional to the T3 concentration in the sample. The assay is performed in clinical laboratory settings by trained personnel. Results assist clinicians in diagnosing and managing thyroid conditions like hyperthyroidism.

Clinical Evidence

Clinical comparison study performed using 68 patient serum samples. Samples were selected to cover a range of T3 levels (low, intermediate, high). Results compared the DSL ACTIVE™ T3 EIA against the DSL ACTIVE™ T3 RIA. Linear regression analysis showed Y = 1.08(X) - 6.0 with a correlation coefficient of r = 0.97.

Technological Characteristics

Competitive enzyme immunoassay (EIA) using microtitration wells coated with Anti-T3 antibody. Detection via spectrophotometric analysis of enzyme-labeled T3 binding. In vitro diagnostic kit format.

Indications for Use

Indicated for the quantitative measurement of T3 in human serum to aid in the diagnosis and treatment of thyroid diseases, including hyperthyroidism.

Regulatory Classification

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.

Predicate Devices

• DSL ACTIVE™ T3 RIA

Submission Summary (Full Text)

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K971270
MAY 22 1997
445 Medical Center Boulevard
445 Medical Center Bldg 1
Webster, Texas 77598-42
Tel [phone]
Fax [phone]
Customer Assistance Center
Tel [phone]
Fax [phone]
Email [e-mail]

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 10-3100 ACTIVE™ T3 EIA Kit
Classification Name: Enzymeimmunoassay, T3
Analyte Code and Name: T3
Regulatory Class: II

Submitter: John Willis
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598
Phone: [phone]

Date: May 14, 1997

The DSL ACTIVE™ T3 EIA kit was developed for the quantitative measurement of T3 in human serum. The EIA 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 (n = 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 comparison gave the equation $Y = 1.08(X) - 6.0$ with a correlation coefficient of $(r) = 0.97$.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

MAY 22 1997

John Willis
Director of Regulatory Affairs
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598

Re: K971270
DSL 10-3100 ACTIVE™ T3 EIA Kit
Regulatory 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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 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.

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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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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: Triiodothyronine (T3) EIA

Indications For Use:

The DSL-10-3100 T3 Enzymeimmunoassay (EIA) Kit provides materials for the quantitative 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.


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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐