Ortho Syphilis-G Antibody ELISA Test

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K883939 ↗

FDA Product Code

LIP

Device Class

Class II

Regulation

21 CFR Part 866.3830

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Ortho Diagnostic Systems, Inc. →

• What is the purpose of the Ortho Syphilis-G Antibody ELISA Test?

  The Ortho Syphilis-G Antibody ELISA Test is designed to detect antibodies against Treponema pallidum in a patient's blood sample. It serves as a valuable tool in both screening and diagnostic processes for syphilis, indicating exposure to the bacterium that causes this sexually transmitted infection.

• How is the Ortho Syphilis-G Antibody ELISA Test supplied and what is its intended use?

  The test is supplied as a laboratory test kit intended for professional use in clinical laboratory settings. It is manufactured by Ortho Diagnostic Systems, Inc. and is not described as single-use or reusable in the provided information.

• What is the regulatory status of the Ortho Syphilis-G Antibody ELISA Test?

  The Ortho Syphilis-G Antibody ELISA Test is a Class II device cleared by the FDA under 510(k) K883939. It is substantially equivalent to other devices in its product code category LIP, which relates to laboratory immunology products.

• What does the Ortho Syphilis-G Antibody ELISA Test detect and how does it aid in diagnosis?

  This test detects specific antibodies against Treponema pallidum in a patient's blood sample. By identifying these antibodies, the test helps clinicians determine if a patient has been exposed to the syphilis bacterium, supporting both screening and diagnostic decisions for this sexually transmitted infection.