QUANTA LITE RUBEOLA (MEASLES) IGG

K971620 · Inova Diagnostics, Inc. · LJB · Jul 22, 1997 · Microbiology

Device Facts

• Record ID: K971620
• Device Name: QUANTA LITE RUBEOLA (MEASLES) IGG
• Applicant: Inova Diagnostics, Inc.
• Product Code: LJB · Microbiology
• Decision Date: Jul 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3520
• Device Class: Class 1
• Attributes: Pediatric

Intended Use

The QUANTA Lite TM Rubeola (Measles) IgG ELISA System is designed for the qualitative determination of IgG antibodies to rubeola (measles) in human serum from adult, neonate, and immunocompromised patients. The test system is intended to be used to evaluate serologic evidence of previous infection with rubeola (measles) and as an aid in the diagnosis of rubeola (measles) infection.

Device Story

QUANTA Lite Rubeola (Measles) IgG ELISA is an in vitro diagnostic test kit. It utilizes enzyme-linked immunosorbent assay (ELISA) technology to detect IgG antibodies in human serum samples. The device is intended for use in clinical laboratory settings by trained personnel. The test provides qualitative results to assist healthcare providers in assessing serologic evidence of past rubeola infection or diagnosing current infection. Results are interpreted by clinicians to guide patient management and diagnostic decision-making.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

ELISA-based in vitro diagnostic test kit for qualitative antibody detection. Operates via enzyme-linked immunosorbent assay principle. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for qualitative detection of IgG antibodies to rubeola (measles) in human serum. Applicable to adult, neonate, and immunocompromised patient populations to evaluate previous infection or aid in diagnosis of rubeola infection.

Regulatory Classification

Identification

Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 2 1997

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

Re: K971620

Trade Name: Quanta Lite Rubeola (Measles) IgG Regulatory Class: I Product Code: LJB Dated: April 30, 1997 Received: May 1, 1997

Dear Mr. Myers:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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"

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

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510(k) Number (if known):

Device Name: QUANTA Lite™ Rubeola (Measles) IgG BLISA Teat Kit

## Indications For Use:

The QUANTA Lite TM Rubeola (Measles) IgG ELISA System is designed for the qualitative determination of IgG antibodies to rubeola (measles) in human serum from adult, neonate, and immunocompromised patients. The test system is intended to be used to evaluate serologic evidence of previous infection with rubeola (measles) and as an aid in the diagnosis of rubeola (measles) infection.

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Ale Puh

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(Division Sign-Off) Division of Clinica! Laboratory Devices

510(k) Number _

**Prescription Use**
(Per 21 CFR 801.109)

OR _ .

Over-The Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)