Cleared Traditional

K883938 - ORTHO* SYPHILIS-M ANTIBODY ELISA TEST

K883938 is an FDA 510(k) clearance for ORTHO* SYPHILIS-M ANTIBODY ELISA TEST, manufactured by Ortho Diagnostic Systems, Inc.. The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K883938 · Ortho Diagnostic Systems, Inc. · Microbiology device
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Dec 1988
Decision
94d
Days
Class 2
Risk

K883938 is an FDA 510(k) clearance for the ORTHO* SYPHILIS-M ANTIBODY ELISA TEST. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Ortho Diagnostic Systems, Inc. (Carpinteria, US). The FDA issued a Cleared decision on December 22, 1988 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3830 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ortho Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K883938

510(k) Number K883938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1988
Decision Date December 22, 1988
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LIP Device Classification - Class 2, Special Controls

Product Code LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3830
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - LIP Enzyme Linked Immunoabsorption Assay, Treponema Pallidum

All 25
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K883938.
DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70
K895965 · Diagnostic Chemicals, Ltd. (Usa) · Dec 1990
CAPTIA(R) SYPHILIS M, MODIFICATION
K904524 · Mercia Diagnostics , Ltd. · Dec 1990
MODIFIED CAPTIA(R) SYPHILIS-M
K900654 · Mercia Diagnostics , Ltd. · Mar 1990
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
K883939 · Ortho Diagnostic Systems, Inc. · Dec 1988
CAPTIA(R) SYPHILIS-G
K881425 · Mercia Diagnostics , Ltd. · Aug 1988
CAPTIA(R) SYPHILIS-M
K871548 · Mercia Diagnostics , Ltd. · Aug 1987