The ThyroTest is a whole blood, qualitative assay for the detection of an increased level of TSH (Thyroid Stimulating Hormone). An increase level of TSH can be an indication of primary hypothyroidism. For professional use only.

Device Description

Purified Polyclonal anti TSH antibodies are passively absorbed on the absorbent membrane. Anti-TSH monoclonal antibodies are absorbed on colloidal gold and then mixed in a protein matrix to obtain the final dye conjugate. Once applied to the specimen well, blood sample undergoes vertical capillary filtration through the porous filtration system. The blood cells are retained in the top layers while the liquid phase (plasma) reaches the bottom membrane layer. The buffer, when applied to the specimen well, flows along the bottom membrane layer, mixes with plasma and migrates horizontally along the test membrane. If TSH is present in the sample in concentrations at or above the detection level, labeled antibody-dye conjugates binds to it, forming an antigen-antibody-dye complex. This complex is then captured by antibody immobilized in the Test Zone ("T") of the membrane, producing a visible pink-rose color band on the membrane. A similarly colored conjugate is captured by a parallel immunochemical reaction in the Control Zone ("C") of the membrane. A distinctive control band is the marker of proper test performance.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the ThyroTest device meets them, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

There are no explicit, pre-defined quantitative acceptance criteria stated in the document. However, the study aims to demonstrate substantial equivalence to an FDA-approved predicate device based on measures of agreement and correlation. The "Statement of Safety and Efficacy" section implies that achieving a high correlation, positive agreement, and negative agreement compared to an FDA-cleared method constitutes meeting safety and efficacy requirements.

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance	Comments
Positive Agreement	High Agreement with predicate	81.25%	This is the percentage of actual positives correctly identified by ThyroTest.
Negative Agreement	High Agreement with predicate	97.28%	This is the percentage of actual negatives correctly identified by ThyroTest.
Correlation	High Correlation with predicate	95.50%	Overall agreement between ThyroTest and the predicate device.

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: 289 total participants.
- Data Provenance: The study was a "three center clinical trial." The country of origin is not explicitly stated, nor is there an indication if it was retrospective or prospective. However, clinical trials are generally prospective in nature.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. The ground truth was established by a predicate device, the Abbott AxSYM, not human experts.
- Qualifications of Experts: Not applicable.
Adjudication method for the test set:
- Not applicable. The ground truth was established by a single, pre-existing FDA-approved device (Abbott AxSYM), not through an adjudication process among human readers.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study compared a new device (ThyroTest) to a predicate device (Abbott AxSYM), not human readers with and without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, this was a standalone performance study. The ThyroTest itself is a qualitative assay (a rapid diagnostic test), and its performance was directly compared to the predicate device. While a "trained Laboratory Technician performed testing," this is the standard operation for such a device, and the device's output (positive/negative) is the primary focus of the comparison.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth was established by comparison to the Abbott AxSYM TSH method, which is identified as an "approved FDA TSH method." This serves as a reference standard.
The sample size for the training set:
- The document does not provide information about a separate training set. The clinical trial data (N=289) appears to be the primary dataset for performance evaluation. Rapid diagnostic tests like ThyroTest typically do not have a "training set" in the machine learning sense, as their chemistry and assay design are fixed.
How the ground truth for the training set was established:
- Not applicable, as no separate training set is described. If one were to consider the initial development and validation of the ThyroTest (not detailed in this summary), the ground truth for establishing its operational characteristics would likely have involved comparison to established laboratory methods or reference materials.

Summary

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JUL 2 5 2003

510k Summary

Date of Summary: June 26, 2003

Product Name:

ThyroTest

Sponsor:

ThyroTec, Inc. 1801 Horseshoe Pike, Suite 1 Brandywine Business Center Honey Brook, PA 19344 Tel: 610.942.8970 Fax: 610.942.8973

Manufacturer:

VEDA LAB Rue del'Expansion ZAT du Londeau CERISE-B.P. 181 61006 Alencon Cedex France

Correspondent:

MDC Associates Fran White Regulatory Consultant 163 Cabot Street Beverly, MA 01915 Tel: 978.927.3808 Fax: 978.927.1308 Email: fran@mdcassoc.com

Substantially Equivalent Devices:

Product: ThyroChek One-Step Whole Blood Rapid TSH Assay

Manufacturer: Little Nell Labs, Inc. K990658

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INTENDED USE:

SUMMARY OF TECHNOLOGY:

Once applied to the specimen well, blood sample undergoes vertical capillary filtration through the porous filtration system. The blood cells are retained in the top layers while the liquid phase (plasma) reaches the bottom membrane layer. The buffer, when applied to the specimen well, flows along the bottom membrane layer, mixes with plasma and migrates horizontally along the test membrane. If TSH is present in the sample in concentrations at or above the detection level, labeled antibody-dye conjugates binds to it, forming an antigen-antibody-dye complex. This complex is then captured by antibody immobilized in the Test Zone ("T") of the membrane, producing a visible pink-rose color band on the membrane. A similarly colored conjugate is captured by a parallel immunochemical reaction in the Control Zone ("C") of the membrane. A distinctive control band is the marker of proper test performance.

PERFORMANCE DATA:

A three center clinical trial was done to compare the performance of ThyroTest to an approved FDA TSH method, the Abbott AxSYM. The following is a summary of the data generated.

Total Participants	289
Total ThyroTest Positives	33
True Positives (TP)	26
False Positives (FP)	7
Total Negatives	256
True Negatives	250
False Negatives	6

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Performance Characteristics

	AxSYM Positive	AxSYM Negative	Total
ThyroTest Positive	26	7	33
ThyroTest Negative	6	250	256
Total	32	257	289

Positive Agreement	81.25%
Negative Agreement	97.28%
Correlation	95.50%

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STATEMENT OF SAFETY AND EFFICACY:

The ThyroTest when compared to an FDA cleared TSH method demonstrated a correlation when compared to another FDA cleared method of 96% with a positive agreement of 81% and a negative agreement of 97%.

These data clearly demonstrate the safety and efficacy of the ThyroTest and further confirm the accuracy, sensitivity and specificity of this product when compared to a substantially equivalent device currently being sold for professional use. A trained Laboratory Technician performed testing in a CLIA registered laboratory.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 5 2003

ThyroTec, Inc. c/o Ms. Fran White Regulatory Consultant MDC Associates 163 Cabot Street Beverly, MA 01915

Re: K030912

Trade/Device Name: ThyroTest Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid stimulating hormone test system Regulatory Class: Class II Product Code: JLW Dated: June 26, 2003 Received: June 30, 2003

Dear Ms. White:

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).

Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a stylized bird-like shape. The words "HEALTH & HUMAN SERVICES" are arranged in a circular pattern around the caduceus.

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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 (301) 594-3084. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number: K030912 Device Name: ThyroTest

Indication for Use:

Sean Cooper
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over The Counter Use (Optional Format 1-2-96)

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.