(39 days)
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No
The description details a standard enzyme immunoassay (EIA) kit for measuring thyroxine levels. There is no mention of AI, ML, or any computational methods beyond standard data analysis for performance studies.
No
The device is an in vitro diagnostic (IVD) kit used for the quantitative determination of total thyroxine, which aids in the diagnosis and treatment of thyroid diseases, but it does not directly perform a therapeutic function.
Yes
The device is described as providing "Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases," which explicitly states its role in diagnosis.
No
The device description clearly outlines a physical kit with reagents, microtiter plates, and a process involving chemical reactions and decantation, indicating it is a hardware-based diagnostic assay, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "The quantitative determination of total thyroxine concentration in human serum or plasma... Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases." This clearly indicates the device is used to test samples taken from the human body (in vitro) to provide information for diagnosis and treatment.
- Device Description: The description details a "microplate enzymeimmunoassay (EIA) kit for the determination of total thyroxine (T4) In human serum or plasma." This describes a laboratory test kit designed to analyze biological samples.
- Classification Name: The device classification name is "enzyme immunoassay, non-radiolabeled, total thyroxine - product code 75KLI (per 21 CRF section 862.1700)." This classification falls under the regulatory framework for medical devices, specifically those used for in vitro diagnostics.
All these points strongly support the classification of this device as an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The quantitative determination of total thyroxine concentration in human serum or plasma by a microplate enzymeimmunoassay.Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases.
Product codes (comma separated list FDA assigned to the subject device)
75KLI
Device Description
The Monobind microplate EIA utilizes anti-thyroxine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, calibrators or controls are then added followed by the enzyme-T4 conjugate. A competition reaction results between the native thyroxine in the sample and the added enzyme-T4 conjugate for a limited number of antibody combining sites. After the completion of the incubation period, the enzyme-T4 conlugate is separated from unreacted material by decantation. The activity of the enzyme on the well is quantitated by reaction with suitable substrate to produce color.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalency was based on clinical comparison (linear regression), using 131 specimens from hypothyroid, euthyroid and hyperthyroid populations. The mean values for reference method (coated tube RIA) and this method (microplate EIA) are 8.07 and 8.06 respectively. The equation to a straight line (y= 0.39 + 0.952) and correlation coefficient (0.934) indicates good method agreement. In addition recovery data demonstrated an average recovery of 101.1% when exogenous added thyroxine was introduced into human serum specimens. Similarly, linearly studies showed an average 101.2% when a specimen was diluted and compared to the dose response curve.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation coefficient: 0.934 Average recovery of 101.1% Average 101.2% when a specimen was diluted and compared to the dose response curve.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Monobind total thyroxine (T4) coated tube radioimmunoassay (RIA)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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JUN 1 6 1997
Image /page/0/Picture/2 description: The image is a logo for MONOBIND, INC. The logo features a stylized, interconnected design resembling the letters 'm' and 'b' stacked on top of each other. The letters are bold and black, creating a strong visual impact. Below the symbol, the company name "MONOBIND, INC." is printed in a simple, sans-serif font.
May. 7, 97
510(k) Summarv
Dear Sir:
Monobind Inc. , registration number 2020726, plans to introduce into commercial distribution an enzymelmmunoassay (EIA) kit for the determination of total thyroxine (T4) In human serum or plasma.
The proprietary name is Total Thyroxine (T4) Microplate EIA and the usual name is T4 EIA. This device classification name is - enzyme immunoassay, non-radiolabeled, total thyroxine - product code 75KLI (per 21 CRF section 862.1700).
This device is substantially equivalent to the Monobind total thyroxine (T4) coated tube radioimmunoassay (RIA), which predicates the new device.
The contact individual for this submission is Dr. Frederick R. Jerome.
The Monobind microplate EIA utilizes anti-thyroxine antibody immobilized on the surface of plastic wells of a microtiterplate. Specimens, calibrators or controls are then added followed by the enzyme-T4 conjugate. A competition reaction results between the native thyroxine in the sample and the added enzyme-T4 conjugate for a limited number of antibody combining sites. After the completion of the incubation period, the enzyme-T4 conlugate is separated from unreacted material by decantation. The activity of the enzyme on the well is quantitated by reaction with suitable substrate to produce color.
The Intended use of the device: The quantitative determination of total thyroxine concentration in human serum or plasma by a microplate enzymelmmunoassay.
The technological characteristics of the new device compared to the predicate device are essentially Identical. This Includes the use of the same anti-thyroxine antibody (coated on a plastic surface), identically prepared callbrators, sample size and the composition of the tracer buffer. The sole difference resides in the use of an enzyme tracer compared to a radioisotope.
Substantial equivalency was based on clinical comparison (linear regression), using 131 specimens from hypothyroid, euthyroid and hyperthyroid populations. The mean values for reference method (coated tube RIA) and this method (microplate EIA) are 8.07 and 8.06 respectively. The equation to a straight line (y= 0.39 + 0.952) and correlation coefficient (0.934) indicates good method agreement.
In addition recovery data demonstrated an average recovery of 101.1% when exogenous added thyroxine was introduced into human serum specimens. Similarly, linearly studies showed an average 101.2% when a specimen was diluted and compared to the dose response curve.
729 West 16" Street , Costa Mesa , CA (USA) 92627 Phone: (714) 642-4830 FAX: (714) 650-8459
1
Public Health Service
JUN 16 1997
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Dr. Frederick R. Jerome Monobind, Inc. 729 West 16th Street --Costa Mesa, California 92627
K971709 Re: Total Throxine Microplate EIA (225-300) 学 Regulatory Class: II Product Code: KLI Dated: May 7, 1997 Received: May 8, 1997
Dear Dr. Jerome:
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) requlation (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 Reqister. 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 requlations.
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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 acborizoof 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.
:李 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 Autman
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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Indications for Use Statement
510(k) Number (if known): K971709
Device Name: Total Thyroxine (T4) Microplate EIA
体
The quantitative determination of total thyroxine concentration in human serum or plasma by a microplate enzymeimmunoassay.Measurements obtained from this device are used in the diagnosis and treatment of thyroid diseases.
(Division Sign-Off
Division of Clinical Laboratory vices
510(k) Number. 974709
(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
(Optional Folmat 1-2-96)