K Number
K971103
Device Name
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
Manufacturer
Date Cleared
1997-06-27

(93 days)

Product Code
Regulation Number
862.2560
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.
Device Description
The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use.
More Information

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No
The summary describes a standard automated immunoassay system with a fluorometer and pipettor, and there is no mention of AI, ML, or related concepts.

No.
The device measures analytes to aid in diagnosis and treatment, but it does not directly treat a disorder.

Yes
The "Intended Use / Indications for Use" section states that the system is used to measure analytes in biological fluids which "aid in the diagnosis and treatment of various disorders." This clearly indicates a diagnostic purpose.

No

The device description explicitly states it is a "combination device, utilizing a fluorometer and automated pipettor," which are hardware components.

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

Here's why:

  • Intended Use: The description explicitly states the device is used "to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders." This is a key characteristic of IVD devices, which are used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
  • Biological Fluids: The device measures analytes in "biological fluids," which are the types of specimens typically analyzed by IVD devices (e.g., blood, urine, serum).
  • Clinical Use: The device is intended for "clinical use," indicating it is used in a healthcare setting for patient care, which is consistent with IVD devices.
  • Reagent Series: The device is used in conjunction with the "AIA-PACK reagent series." IVD devices often rely on specific reagents to perform the diagnostic tests.

The combination of measuring analytes in biological fluids for diagnostic and treatment purposes in a clinical setting strongly indicates that the AIA NexIA Automated Enzyme Immunoassay System is an In Vitro Diagnostic device.

N/A

Intended Use / Indications for Use

The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.

Product codes

KHO

Device Description

The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use.

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

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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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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§ 862.2560 Fluorometer for clinical use.

(a)
Identification. A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, both rendered in black.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Lori Robinson JUN 27 1997 Manager, Quality Assurance Tosoh Medies, Inc. -373 D Vintage Park Drive Foster City, California 94404

Re : K971103 AIA NexIA Automated Enzyme Immunoassay System Regulatory Class: I Product Code: KHO Dated: June 10, 1997 Received: June 11, 1997

Dear Ms. Robinson:

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 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 requlations 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 requirement, 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 Reqister. 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 Requlations .

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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/dsmamain.html".

sincerely yours,
Steven Gutman

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

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TOSOH MEDICS, INC.

PREMARKET NOTIFICATION

INDICATION FOR USE STATEMENT

AIA NexIA Automated Enzyme Immunoassay System

The AIA NexIA Automated Enzyme Immunoassay System is a combination device, utilizing a fluorometer and automated pipettor, intended for clinical use. The NexlA is used in conjunction with the AIA-PACK reagent series to measure a variety of analytes in biological fluids which aid in the diagnosis and treatment of various disorders.

P.Bernhardt 6/24/97
(fornwn)
✓ for prescription use
(per 21 CFR 801.101)
K971103

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