QUANTA LITE REBELLA IGG

• K Number: K971304
• Device Name: QUANTA LITE REBELLA IGG
• Manufacturer: INOVA DIAGNOSTICS, INC.
• Date Cleared: 1998-01-02 ( 269 days)
• Product Code: LFX
• Regulation Number: 866.3510
• Type: Traditional
• Panel: Microbiology
• Age Range: All
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

The QUANTA Lite™ Rubella IgG kit is intended as an in vitro diagnostic assay for the semi-quantitative or quantitative detection rubella IgG antibodies in single sera for evaluation of immune status or in paired sera to demonstrate seroconversion.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the QUANTA Lite™ RUBELLA IgG ELISA test kit. It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested. The letter primarily states that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot extract the requested information from the provided text.

Summary

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Food and Drug Administration Rockville MD 20850

JAN - 2 1998

Mr. Brys C. Myers Manager, Regulatory Affairs Inova Diagnostics, Inc. 10451 Roselle Street San Diego, CA 92121

Re: K971304

Trade Name: QUANTA Lite™ RUBELLA IgG ELISA Regulatory Class: III Product Code: LFX Date: December 17, 1997 Received: December 18, 1997

Dear Mr. Myers:

We have reviewed vour 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 at [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerelv yours.

Steven Autman

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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Ka71304 510(k) Number (if known):

Forme: QUANTA Lite™ Rubella IgG BLISA Test Kit

Indications For Use:

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The QUANTA Lite™ Rubella IgG kit is intended as an in vitro diagnostic assay for the semi-quantitative or quantitative detection rubella IgG antibodies in single sera for evaluation of immune status or in paired sera to demonstrate seroconversion.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joffett

(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number_14971304

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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Regulation Number and Section

§ 866.3510 Rubella virus serological reagents.

(a)
Identification. Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).(b)
Classification. Class II. The special controls for this device are:(1) National Committee for Clinical Laboratory Standards':
(i) 1/LA6 “Detection and Quantitation of Rubella IgG Antibody: Evaluation and Performance Criteria for Multiple Component Test Products, Speciment Handling, and Use of the Test Products in the Clinical Laboratory, October 1997,”
(ii) 1/LA18 “Specifications for Immunological Testing for Infectious Diseases, December 1994,”
(iii) D13 “Agglutination Characteristics, Methodology, Limitations, and Clinical Validation, October 1993,”
(iv) EP5 “Evaluation of Precision Performance of Clinical Chemistry Devices, February 1999,” and
(v) EP10 “Preliminary Evaluation of the Linearity of Quantitive Clinical Laboratory Methods, May 1998,”
(2) Centers for Disease Control's:
(i) Low Titer Rubella Standard,
(ii) Reference Panel of Well Characterized Rubella Sera, and
(3) World Health Organization's International Rubella Standard.