(507 days)
No
The device description details a standard immunoassay (ELISA) based on antibody-antigen binding and enzymatic color development. There is no mention of AI or ML algorithms for data analysis, interpretation, or decision-making. The performance study compares the results to a predicate RIA method, which is also a traditional immunoassay technique.
No
This device is an in vitro diagnostic test system for quantitative determination of TSH, used to screen newborns for congenital hypothyroidism. It is not used for treatment or therapy.
Yes
The "Intended Use / Indications for Use" states that the device is "an in vitro diagnostic test system for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood... It is intended to be used to screen newborns for congenital hypothyroidism." The term "in vitro diagnostic test system" directly indicates its diagnostic purpose.
No
The device description clearly outlines a physical, in vitro diagnostic test system involving reagents, microwells, and enzymatic reactions, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro diagnostic test system."
- Purpose: It is designed to quantitatively determine thyroid stimulating hormone (TSH) in human whole blood, which is a biological sample.
- Clinical Application: The intended use is to "screen newborns for congenital hypothyroidism," which is a medical condition.
- Method: The "Device Description" details a laboratory-based immunoassay method (ELISA) performed on a microwell plate, which is characteristic of in vitro testing.
All of these points align with the definition of an In Vitro Diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
The Monobind AccuBind Neo-TSH Microwell Elisa Assay is an in vitro diagnostic test system for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood dried on Whatman 903 filter paper. It is intended to be used to screen newborns for congenital hypothyroidism.
Product codes
JLW
Device Description
The Monobind AccuBind™ Neonatal TSH Elisa Assay is a solid phase two-site immunoenzymometric assay based on the direct sandwich technique in which two specific antibodies are directed against two separate antigenic determinants on the hTSH molecule.
In this method, TSH dried whole blood callbrator, patient specimen or control is first added to a streptavidin coated well. Elution buffer containing biotinylated monoclonal antibodies are added and the reactants mixed. Reaction between the biotinylated Anti-TSH and the TSH in the dried blood spot forms a complex that binds to the streptavidin coated to the inherent affinity of streptavidin and biotin.
After the completion of the first incubation period, excess reactants are washed off via a wash step and the enzyme conjugate (another specific anti-TSH antibody linked to an enzyme) is added to the Ag-Ab complex deposited on the plastic surface. The enzyme labeled Anti-TSH antibody binds to the TSH making a sandwich complex with two antibodies bound to the antigen during a second incubation. The microplate is washed to remove unreacted enzyme. Finally, the activity of the enzyme present on the surface of the well is quantitated by reaction with a suitable substrate to produce color.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
newborns
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The hTSH concentrations were measured in 158 newborn samples with AccuBind™ Neo-TSH microwell Elisa kit and DPC IRMA (RIA) kit. The total range when measured with the AccuBind Neo-TSH Elisa kit was 0.7 to 25.52 µIU/ml with a mean of 8.31 µIU/ml. The total range for the DPC RIA method was 0.61 to 26.6 µlU/ml with a mean of 8.87 µIU/ml of whole blood.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1690 Thyroid stimulating hormone test system.
(a)
Identification. A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.(b)
Classification. Class II.
0
Monobind, Inc.
- 4 200
510(k) Safety and Effectiveness Summary
| Re: | 510-K Summary |
|---|---|
| Date: | October 27, 2006. |
| Submitter: | Monobind Inc, |
| 100 North Pointe | |
| Lake Forest. CA 92630. | |
| Contact: | Dr. Jay Singh |
| Trade Name: | AccuBind™ Neo-TSH Microwell Elisa Kit. |
| Regulation Number | 862.1690 |
| Product Code | JLW |
| Common Name: | Neonatal TSH Elisa |
| Classification Name: | Thyroid Stimulating Hormone Test System |
| Predicate Device: | Neonatal TSH RIA Kit (I-125) 510(k)# K772192 |
Device Description:
The Monobind AccuBind™ Neonatal TSH Elisa Assay is a solid phase two-site immunoenzymometric assay based on the direct sandwich technique in which two specific antibodies are directed against two separate antigenic determinants on the hTSH molecule.
In this method, TSH dried whole blood callbrator, patient specimen or control is first added to a streptavidin coated well. Elution buffer containing biotinylated monoclonal antibodies are added and the reactants mixed. Reaction between the biotinylated Anti-TSH and the TSH in the dried blood spot forms a complex that binds to the streptavidin coated to the inherent affinity of streptavidin and biotin.
After the completion of the first incubation period, excess reactants are washed off via a wash step and the enzyme conjugate (another specific anti-TSH antibody linked to an enzyme) is added to the Ag-Ab complex deposited on the plastic surface. The enzyme labeled Anti-TSH antibody binds to the TSH making a sandwich complex with two antibodies bound to the antigen during a second incubation. The microplate is washed to remove unreacted enzyme. Finally, the activity of the enzyme present on the surface of the well is quantitated by reaction with a suitable substrate to produce color.
Intended Use:
The Monobind AccuBind Neo-TSH Microwell Elisa Assay is an in vitro diagnostic test system for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood dried on Whatman 903 filter paper. It is intended to be used to screen newborns for congenital hypothyroidism.
100 North Pointe, Lake Forest. CA 92630 USA Tel: (949) 951-2665 · FAX (949) 951-3539 http://www.monobind.com
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Image /page/1/Picture/0 description: The image shows the logo for Monobind, Inc. The logo features a stylized, interconnected "MB" design in bold, black lines. Below the symbol, the company name "Monobind, Inc." is printed in a simple, sans-serif font.
Equivalence Comparison:
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 in the market, marketed by Diagnostics Products Corporation, Los Angeles. California, distributed as Neonatal TSH RIA Kit.
The hTSH concentrations were measured in 158 newborn samples with AccuBind™ Neo-TSH microwell Elisa kit and DPC IRMA (RIA) kit. The total range when measured with the AccuBind Neo-TSH Elisa kit was 0.7 to 25.52 µIU/ml with a mean of 8.31 µIU/ml. The total range for the DPC RIA method was 0.61 to 26.6 µlU/ml with a mean of 8.87 µIU/ml of whole blood. The frequency distribution are shown in the following figure.
Image /page/1/Figure/4 description: This bar graph compares the number of samples for Predicate and Monobind at different (uIU/ml) values. The x-axis shows the (uIU/ml) values, ranging from 0 to 50, with intervals such as (0-5), (5-10), (10-20), and (20-30). The y-axis represents the number of samples, ranging from 0 to 70. At (10-20) (uIU/ml), both Predicate and Monobind have approximately 56-60 samples.
Normal Sample Distribution
The device is an in vitro diagnostic test kit. And, the results obtained with are to be interpreted in conjunction with other relevant information available to the clinicians.
This device has no environmental impact.
The performance data and clinical data are on file and are available to any qualified individual upon request. Monobind is responsible and attests that all information submitted is true and authentic to the best of our knowledge.
Sincerely,
Jay Singh Director R&D.
Frederick Jerome President
100 North Pointe, Lake Forest. CA 92630 USA Tel: (949) 951-2665 · FAX (949) 951-3539 http://www.monobind.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the bird. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR - 4 2008
Monobind, Inc. c/o Dr. Jay Singh Director R & D 100 N. Pointe Drive Lake Forest, CA 92630
Re: K063437
Trade/Device Name: AccuBind Neo-TSH Microwell Elisa Assay Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system. Regulatory Class: Class II Product Code: JLW Dated: March 25, 2008 Received: March 27, 2008
Dear Dr. Singh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K063437
Device Name: AccuBind™Neo-TSH Microwell Elisa Assay
Indications For Use: The Monobind AccuBind Neo-TSH Microwell Elisa Assay is an in vitro diagnostic test system for the quantitative determination of thyroid stimulating hormone (TSH) in human whole blood dried on Whatman 903 filter paper. It is intended to be used to screen newborns for congenital hypothyroidism.
Prescription Use _ ∑
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division/Sign-Off
of In Vitro Diagnostic Device
510(k) L063437