EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT

K061239 · Euroimmun Us, LLC · MYF · Jun 28, 2007 · Microbiology

Device Facts

• Record ID: K061239
• Device Name: EUROIMMUN ANTI-HSV-2 ELISA (IGG) AND ANTI-HSV-1 ELISA (IGG) KIT
• Applicant: Euroimmun Us, LLC
• Product Code: MYF · Microbiology
• Decision Date: Jun 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3305
• Device Class: Class 2

Intended Use

The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection with EUROIMMUN Anti-HSV-2 EUSA (IgG) in persons suspected of herpes viral infection. The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection with EUROIMMUN Anti-HSV-1 EUSA (lgG) in persons suspected of herpes viral infection.

Device Story

In vitro diagnostic ELISA kits for qualitative detection of IgG antibodies against HSV-1 and HSV-2; utilizes human serum samples; detects specific viral glycoproteins (C1 for HSV-1, G2 for HSV-2); intended for use in clinical laboratory settings by trained personnel; results aid in presumptive diagnosis of type-specific HSV infection; supports clinical decision-making regarding patient management for suspected herpes viral infections.

Clinical Evidence

Clinical performance evaluated across multiple studies (n=397 for HSV-1; n=421 for HSV-2) using Western blot as reference. HSV-1 sensitivity ranged 98.1-100%; specificity 71.4-100%. HSV-2 sensitivity ranged 94.5-100%; specificity 76.9-100%. Comparison to predicate kits showed high agreement (HSV-1: 96.5% negative, 98.3% positive; HSV-2: 97.4% negative, 93.9% positive). Type specificity confirmed at 97.6% (HSV-1) and 97.0% (HSV-2).

Technological Characteristics

ELISA-based immunoassay. Microtiter wells coated with affinity-purified HSV-1 glycoprotein C1 or HSV-2 glycoprotein G2. Detection via rabbit anti-human IgG HRP conjugate and TMB substrate. Qualitative output. Manual or automated plate processing.

Indications for Use

Indicated for qualitative detection of IgG antibodies against HSV-1 (glycoprotein C1) or HSV-2 (glycoprotein G2) in human serum. Used for presumptive diagnosis of type-specific HSV infection in patients suspected of herpes viral infection.

Regulatory Classification

Identification

Herpes simplex virus serological assays are devices that consist of antigens and antisera used in various serological tests to identify antibodies to herpes simplex virus in serum. Additionally, some of the assays consist of herpes simplex virus antisera conjugated with a fluorescent dye (immunofluorescent assays) used to identify herpes simplex virus directly from clinical specimens or tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of diseases caused by herpes simplex viruses and provides epidemiological information on these diseases. Herpes simplex viral infections range from common and mild lesions of the skin and mucous membranes to a severe form of encephalitis (inflammation of the brain). Neonatal herpes virus infections range from a mild infection to a severe generalized disease with a fatal outcome.

Special Controls

*Classification.* Class II (special controls). The device is classified as class II (special controls). The special control for the device is FDA's revised guidance document entitled “Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays.” For availability of the guidance revised document, see § 866.1(e).

Submission Summary (Full Text)

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Kathryn Kohl Managing Director Operations, Scientific & Regulatory EUROIMMUN US LLC 429 Rockaway Valley Road, Unit 1200 Boonton Township, New Jersey 07005

JUN 2 8 2007

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Re: k061239

Trade/Device Name: EUROIMMUN Anti-HSV-1 ELISA (IgG) Kit EUROIMMUN Anti-HSV-2 ELISA (IgG) Kit Regulation Number: 21CFR 866. 3305 Regulation Name: Herpes Simplex Virus Serological Reagents Regulatory Class: Class II Product Code: MXJ and MYF Dated: April 28, 2006 Received: May 3, 2006

Dear Ms. Kohl:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed

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predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone], or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Sally a Hogns

Sally A. Hojvat, M.Sc., Ph.D. Director Division of Microbiology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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## EUROIMMUN US, LLC

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ATTACHMENT 1

## INDICATIONS FOR USE STATEMENT

KO61239 510(k) Number (if known):

Device Name: Anti-HSV-1 ELISA (IgG)

Indications For Use:

The EUROIMMUN Anti-HSV-1 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against Herpes simplex virus type 1 (HSV-1) specific glycoprotein C1 in human serum. It is intended for the presumptive diagnosis of type specific HSV-1 infection with EUROIMMUN Anti-HSV-2 EUSA (IgG) in persons suspected of herpes viral infection.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Sally adams

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Division Sign-Off

Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) k061239

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ATTACHMENT 2

## INDICATIONS FOR USE STATEMENT

KOK12 510(k) Number (if known):

Anti-HSV-2 ELISA (IgG) Device Name:

Indications For Use:

The EUROIMMUN Anti-HSV-2 ELISA (IgG) is intended for the qualitative determination of IgG class antibodies against herpes simplex virus type 2 (HSV-2) specific glycoprotein G2 in human serum. It is intended for the presumptive diagnosis of type specific HSV-2 infection with EUROIMMUN Anti-HSV-1 EUSA (lgG) in persons suspected of herpes viral infection.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (OIVD)

Jall a Hgnb
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

51004 K061239