K960412 · Biomerica, Inc. · CDP · Mar 19, 1996 · Clinical Chemistry
Device Facts
Record ID
K960412
Device Name
T-3 MICROWELL EIA MODEL 7013
Applicant
Biomerica, Inc.
Product Code
CDP · Clinical Chemistry
Decision Date
Mar 19, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 862.1710
Device Class
Class 2
Indications for Use
Biomerica's T3 microwell EIA is Enzyme Immuno-assay test for the quantitative determination of Triiodothyronine (T3) in human serum.
Device Story
In vitro diagnostic enzyme immunoassay (EIA) kit; measures T3 levels in human serum/plasma. Principle: competitive solid-phase immunoassay; T3 in sample and enzyme-labeled T3 conjugate compete for limited antibody binding sites on microwell surface. Unbound conjugate washed away; chromogen substrate added. Color intensity measured via microtiter reader; inversely proportional to T3 concentration. Results determined by extrapolating from dose-response curve (DRC) plotted from known T3 concentrations. Used in clinical laboratory settings by trained technicians. Output assists clinicians in diagnosing/monitoring thyroid function.
Clinical Evidence
No clinical data provided in summary; performance data stated to be on file.
Technological Characteristics
Solid-phase enzyme immunoassay; 96-well microtiter plate format; antibody-coated microwells; enzyme-labeled T3 conjugate; chromogen substrate; microtiter reader required for absorbance measurement.
Indications for Use
Indicated for quantitative determination of T3 in human serum or plasma for patients requiring thyroid function assessment.
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
T3 Coat-a-Count RIA test (DPC kit)
Submission Summary (Full Text)
{0}
K960412
# 510 (K) Summary Statement
To The Reviewer:
Biomerica's T3 microwell EIA is Enzyme Immuno-assay test for the quantitative determination of Triiodothyronine (T3) in human serum. This test is substantially equivalent to T3 Coat-a-Count RIA test (DPC kit) for the quantitative determination of T3 in human serum.
This device is an in vitro diagnostic test kit.
Biomerica's T3 EIA is a sensitive solid phase enzyme immunoassay system for the quantitative determination of T3 in patient serum or plasma. Specific antibodies to T3 are immobilized on the inside surface of microwells of microtiter plate (96). A known volume of serum or plasma containing T3 and an enzyme labeled T3 conjugate are added to the antibody coated microwells. Both the T3 in the sample and the enzyme conjugated T3 compete for a limited number of binding sites available on the antibody. The unbound T3-enzyme conjugate is washed off from the microwells. A chromogen substrate mixture is added to the bound T3 enzyme conjugate to develop color. The intensity of the color developed is measured by the microtiter reader and is inversely proportional to the amount of T3 present in the patient's sample. The quantity of T3 present in the patient's sample (serum or plasma) is measured by extrapolating from the dose response curve (DRC).
DRC is prepared by plotting known concentrations of T3 on X-axis and the corresponding color absorbance on Y-axis, using a semi-log graph sheet or a Software program for microtiter plate reader.
Data submitted in this 510 (K) premarket notification is correct and has been compared to be substantially equivalent to a 510 (K) cleared commercially available predicate device (DPC RIA kit) in the market.
The performance data and clinical data is on file and is available to any qualified individual upon request. Biomerica is responsible for all of the information submitted which is true and authentic to the best of our knowledge.
Sincerely,
Perry G. Rucker
Manager, Regulatory Affairs
