EUROIMMUN LYME ELISA(IgG/IgM)

K142038 · Euroimmun US · LSR · May 4, 2015 · Microbiology

Device Facts

• Record ID: K142038
• Device Name: EUROIMMUN LYME ELISA(IgG/IgM)
• Applicant: Euroimmun US
• Product Code: LSR · Microbiology
• Decision Date: May 4, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.3830
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The EUROIMMUN Lyme ELISA (IgG/IgM) test kit is intended for the qualitative determination of IgG and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K⁺-EDTA, Li⁺-heparin) from symptomatic patients or people suspected of B. burgdorferi infection. It is used as an aid in the diagnosis of Lyme disease, in conjunction with other laboratory and clinical findings. All positive and borderline results should be supplemented by a second step testing method such as Western blot.

Device Story

EUROIMMUN Lyme ELISA (IgG/IgM) is an in vitro diagnostic test kit for detecting antibodies against Borrelia burgdorferi. Input: human serum or plasma samples. Principle: Enzyme-linked immunosorbent assay (ELISA) to identify IgG/IgM class antibodies. Output: qualitative determination of antibody presence. Used in clinical laboratory settings by trained laboratory personnel. Results assist clinicians in diagnosing Lyme disease when interpreted alongside patient symptoms and other clinical findings. Positive or borderline results necessitate confirmatory testing using a second-step method like Western blot to improve diagnostic accuracy.

Clinical Evidence

No clinical data provided in the document.

Technological Characteristics

In vitro diagnostic ELISA test kit for qualitative antibody detection. Analyzes human serum and plasma (K2-EDTA, Li-heparin).

Indications for Use

Indicated for symptomatic patients or individuals suspected of Borrelia burgdorferi infection to aid in the diagnosis of Lyme disease. Applicable to adults and children (age range 2-80 years).

Regulatory Classification

Identification

Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), the Treponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies to Treponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genus Treponema and provides epidemiological information on syphilis.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 4, 2015

EUROIMMUN US MICHAEL LOCKE DIRECTOR OF REGULATORY AFFAIRS 1100 THE AMERICAN ROAD MORRIS PLAINS NJ 07950

Re: K142038

Trade/Device Name: EUROIMMUN Lyme ELISA (IgG/IgM) Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema pallidum treponemal test reagents Regulatory Class: II Product Code: LSR Dated: July 24, 2014 Received: July 28, 2014

Dear Mr. Locke:

This letter corrects our substantially equivalent letter of May 4, 2015.

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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Page 2 - Mr. Locke

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] ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

# Sally A. Hoivat -S

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

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K142038

#### Device Name

EUROIMMUN Lyme ELISA (IgG/IgM)

#### Indications for Use (Describe)

The EUROIMMUN Lyme ELISA (IgG/IgM) test kit is intended for the qualitative determination of IgC and/or IgM class antibodies against Borrelia burgdorferi in human serum and plasma (K++EDTA, Li+-heparin) from symptomatic patients or people suspected of B. burgdorferi infection. It is used as an aid in the disease, in conjunction with other laboratory and clinical findings. All positive and borderline results should be supplemented by a second step testing method such as Western blot.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sally A. Hojvat -S 2015.05.04 15:27:12 -04'00'

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