K Number
K991252
Device Name
AIA-PACK FT3 ASSAY
Manufacturer
Date Cleared
1999-05-11

(28 days)

Product Code
Regulation Number
862.1710
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.
Device Description
Not Found
More Information

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Not Found

No
The summary describes an in vitro diagnostic assay for measuring Free Triiodothyronine and contains no mention of AI or ML technology.

No
The device is for in vitro diagnostic use, meaning it aids in diagnosis rather than directly treating a condition.

Yes
The "Intended Use / Indications for Use" section explicitly states "IN VITRO DIAGNOSTIC USE ONLY" and "Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases," which directly indicates it is a diagnostic device.

No

The 510(k) summary describes an in vitro diagnostic (IVD) device intended for use on TOSOH AIA System analyzers, which are hardware systems. The summary does not mention any software-only components or functions.

Yes, based on the provided information, this device is an IVD (In Vitro Diagnostic).

The "Intended Use / Indications for Use" section explicitly states:

  • "AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY..."
  • "...Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases."

These statements clearly indicate that the device is intended for use outside of the body to examine specimens (human serum) and provide information for the diagnosis and treatment of a disease. This aligns perfectly with the definition of an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Product codes

CDP

Device Description

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Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

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Anatomical Site

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Indicated Patient Age Range

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Intended User / Care Setting

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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)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

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Predicate Device(s)

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Reference Device(s)

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Predetermined Change Control Plan (PCCP) - All Relevant Information

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§ 862.1710 Total triiodothyronine test system.

(a)
Identification. A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.(b)
Classification. Class II. This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract human profiles facing to the right, with flowing lines suggesting movement or connection. The logo is presented in black and white.

MAY 1 1 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Lois Nakayama Manager. Ouality Assurance Tosoh Medics, Inc. 347 Oyster Point Boulevard, Suite 201 South San Francisco, California 94080

K991252 Re: Trade Name: AIA-PACK FT3 Assay Regulatory Class: II Product Code: CDP Dated: April 12, 1999 Received: April 13, 1999

Dear Ms. Nakayama:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

510(k) Number (if known): ______________K991252

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

AIA-PACK FT3 is intended for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of Free Triiodothyronine in human serum on TOSOH AIA System analyzers. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

Scan Cooper

(Division Sign-Off)
Division of Clinical Laboratory vices
510(k) Number K991252

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)