Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

K234091 · Genalyte, Inc. · JLW · Jul 22, 2024 · Clinical Chemistry

Device Facts

• Record ID: K234091
• Device Name: Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
• Applicant: Genalyte, Inc.
• Product Code: JLW · Clinical Chemistry
• Decision Date: Jul 22, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1690
• Device Class: Class 2

Intended Use

The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders. The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system’s assay applications utilize silicon photonics technology.

Device Story

Maverick Diagnostic System TC1000 is an automated immunoassay analyzer; utilizes silicon photonics technology for analyte detection. Input: human serum or K2EDTA plasma samples. Operation: system performs quantitative determination of TSH; results provided to clinical laboratory personnel. Output: quantitative TSH concentration values. Clinical utility: aids in diagnosis of thyroid or pituitary disorders. Used in clinical laboratory environments by trained professionals.

Clinical Evidence

Bench testing only. Analytical performance established via precision (repeatability/reproducibility), linearity (0.12–25.45 µIU/mL), interference, cross-reactivity, and limit of quantitation (0.20 µIU/mL). Method comparison against predicate (N=127/125) showed high correlation (R²=0.95–0.96). Reference range established using 120 healthy individuals.

Technological Characteristics

Silicon photonics ring resonance sensing; sandwich immunoassay. Instrument: automated analyzer with laser/photodiode optics, fluidics, and cloud-based data processing. Consumables: silicon chip with capture antibodies, pre-filled stripwells. Connectivity: cloud-based protocol retrieval and data processing. Sterilization: not specified. Standards: CLSI EP05-A3, EP06-Ed2, EP07-A3, EP09c, EP28-A3c, EP37; IEC 62304, 60601-1, 60601-1-2.

Indications for Use

Indicated for quantitative determination of human thyroid stimulating hormone (TSH) in human serum and K2EDTA plasma for the diagnosis of thyroid or pituitary disorders in clinical laboratory settings.

Regulatory Classification

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.

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

July 22, 2024

Genalyte, Inc. Sasi Mudumba Senior Director of IVD & Clinical Regulatory 6620 Mesa Ridge Road San Diego, California 92121

Re: K234091

Trade/Device Name: Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0 Regulation Number: 21 CFR 862.1690 Regulation Name: Thyroid Stimulating Hormone Test System Regulatory Class: Class II Product Code: JLW, JJE Dated: June 21, 2024 Received: June 21, 2024

Dear Sasi Mudumba:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

{1}------------------------------------------------

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

Thomas C. Miller Date: 2024.07.22 22:38:56 -04'00' -5 for Paula Caposion, Ph.D. Deputy Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K234091

Device Name Maverick Diagnostic System TC1000 Maverick Test Panel A0.B0

## Indications for Use (Describe)

The Maverick Test Panel A0.B0 is an immunoassay for the quantitative determination of human thyroid stimulating hormone (thyrotropin, TSH) in human serum and K2EDTA plasma on the Maverick Diagnostic System TC1000. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Maverick Diagnostic System TC1000 is an automated immunoassay analyzer intended for in vitro diagnostic use to determine analytes in a clinical laboratory. The system's assay applications utilize silicon photonics technology.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;"> </span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."