AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

K971103 · Tosoh Medics, Inc. · KHO · Jun 27, 1997 · Clinical Chemistry

Device Facts

• Record ID: K971103
• Device Name: AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
• Applicant: Tosoh Medics, Inc.
• Product Code: KHO · Clinical Chemistry
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2560
• Device Class: Class 1

Intended Use

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

AIA NexIA is an automated enzyme immunoassay system for clinical laboratory use. It integrates a fluorometer and an automated pipettor to process biological fluid samples. The system operates in conjunction with AIA-PACK reagent series to perform quantitative measurements of various analytes. The device automates the immunoassay workflow, providing results that assist healthcare providers in diagnosing and treating medical disorders. It is designed for operation by laboratory personnel in a clinical setting.

Technological Characteristics

Combination device consisting of a fluorometer and automated pipettor. Designed for use with AIA-PACK reagent series for enzyme immunoassay analysis. System is automated for clinical laboratory environments.

Indications for Use

Indicated for clinical use in measuring analytes in biological fluids to aid in the diagnosis and treatment of various disorders. Intended for prescription use.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

Lori Robinson
JUN 27 1997
Manager, Quality Assurance
Tosoh Medics, 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 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 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 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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 NexIA 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 4/20/97
(for nwn)

☑ for prescription use
(per 21 CFR 801.109)
K971103

0025

373 D Vintage Park Drive, Foster City, California 94404 Tel. [phone] Toll free: 1-800/248-6764 Fax: [phone]