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.

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.

AI/ML Overview

The provided document describes the Monobind AccuBind Neo-TSH Microwell Elisa Kit, an in vitro diagnostic test system for screening newborns for congenital hypothyroidism by quantitatively determining thyroid stimulating hormone (TSH) in dried whole blood.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined "acceptance criteria" in terms of specific thresholds for agreement or performance metrics. Instead, it relies on a comparative effectiveness study against a predicate device to demonstrate substantial equivalence. The implicit acceptance criterion is that the new device's performance should be comparable to the predicate device.

Acceptance Criteria (Implicit)	Reported Device Performance (Monobind AccuBind Neo-TSH Elisa kit)	Reported Device Performance (Predicate Device: DPC IRMA (RIA) kit)
Comparable hTSH concentration range	0.7 to 25.52 µIU/ml	0.61 to 26.6 µlU/ml
Comparable mean hTSH concentration	8.31 µIU/ml	8.87 µIU/ml
Comparable frequency distribution of hTSH concentrations	Visually comparable in the provided bar graph for "Normal Sample Distribution"	Visually comparable in the provided bar graph for "Normal Sample Distribution"

2. Sample Size and Data Provenance for the Test Set

Sample Size: 158 newborn samples.
Data Provenance: The document does not explicitly state the country of origin. It is a retrospective comparison as the samples were measured with both the new device and the existing predicate device.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth. The comparison is made against a legally marketed predicate device, with its results serving as the reference for comparison.

4. Adjudication Method for the Test Set

None specified. The study compares the measurements of two different assay methods directly. There is no indication of an adjudication process to reconcile discrepancies between the two device readings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC study was not done. This is an in vitro diagnostic test for measuring TSH levels. The study involves comparing the quantitative results of two different assay kits on a set of samples, not the interpretation of results by human readers. Therefore, the concept of "human readers improving with AI vs without AI assistance" is not applicable here.

6. Standalone (Algorithm Only) Performance

Yes, a standalone performance was done. The Monobind AccuBind Neo-TSH Microwell Elisa Kit is an in vitro diagnostic test, and its performance (quantitative measurement of TSH) is assessed as a standalone device by comparing its output with that of a predicate device. The results (hTSH concentrations) are directly generated by the assay kit.

7. Type of Ground Truth Used

The ground truth used is effectively the results obtained from the legally marketed predicate device (Neonatal TSH RIA Kit (I-125) 510(k)# K772192). The study's objective is to show substantial equivalence to this predicate device. This is a form of "reference standard" or "comparator device" ground truth.

8. Sample Size for the Training Set

The document does not provide information regarding a "training set" or its sample size. This type of device (Elisa kit) typically undergoes analytical validation and clinical validation. While some internal development (which could involve "training" in a broad sense for assay optimization) would have occurred, the document focuses on the premarket notification and equivalence comparison, which uses a test set of 158 samples. It's unlikely that a distinct "training set" as understood in machine learning contexts would be explicitly reported for this type of IVD.

9. How Ground Truth for the Training Set Was Established

As no training set is discussed or explicitly defined in the document, no information is provided on how its ground truth would have been established.

Summary

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Image of Monobind, Inc. logo

Monobind, Inc.

K063437

4 200

510(k) Safety and Effectiveness Summary

Re:	510-K Summary
Date:	October 27, 2006.
Submitter:	Monobind Inc,100 North PointeLake 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:

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:

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

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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

Regulation Number and Section

§ 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.