ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300

K030860 · Monobind · KLI · Aug 22, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030860
• Device Name: ACCUBIND NEONATAL T4 MICROPLATE EIA, MODEL 2625-300
• Applicant: Monobind
• Product Code: KLI · Clinical Chemistry
• Decision Date: Aug 22, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

This test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on filter paper for screening newborns for congenital (neonatal) hypothyroidism.

Device Story

AccuBind™ Neo-Natal T4 Microplate EIA is an enzyme immunoassay (EIA) for quantitative T4 measurement in dried blood spot specimens. Used in clinical laboratories for neonatal screening programs to detect congenital hypothyroidism. Device utilizes microplate-based immunoassay technology; samples are processed to extract T4, which competes with enzyme-labeled T4 for binding sites on antibody-coated microplate wells. After incubation and washing, substrate addition produces color intensity inversely proportional to T4 concentration. Results are measured via spectrophotometry. Healthcare providers use these quantitative results to identify newborns requiring further diagnostic follow-up for hypothyroidism, facilitating early intervention.

Clinical Evidence

No clinical data provided; substantial equivalence established via bench testing and performance validation of the immunoassay system.

Technological Characteristics

Solid-phase enzyme immunoassay (EIA). Microplate format. Requires microplate reader (450nm/620nm). Uses S&S 903 filter paper for dried blood spots. Non-radioactive detection.

Indications for Use

Indicated for quantitative determination of Thyroxine (T4) in dried blood spot specimens for screening newborns for congenital (neonatal) hypothyroidism.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 2 2003

Dr. Jay Singh Consultant, Regulatory Affairs Monobind. Inc. 729 West 16th Street, Suite C-4 Costa Mesa, CA 92627

Re: k030860

Trade/Device Name: AccuBind™ Neo-Natal T4 Microplate EIA Regulation Number: 21 CFR 862.1700 Regulation Name: Total thyroxine test system Regulatory Class: Class II Product Code: KLI Dated: June 27, 2003 Received: July 1, 2003

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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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 [phone]. 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 [phone] or [phone] 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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## Indications for Use

510(k) Number (if known): K030860

Device Name: AccuBind™ Neo-Natal T4 Microplate ElA

The test is intended for the quantitative determination of Thyroxine (T4) in blood specimens dried on the filter paper for screening newborns for congenital (neonatal) hypothyroidism.

PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IF NEEDED.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use:

OR

Over-The-Counter (OTC) Use

(Per 21CFR 801.109)

(Optional Format 1-2-96).

Carol C Benson for Jean Cooper, Dr
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) k030860