Cleared Traditional

K895965 - DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70

K895965 is the FDA 510(k) clearance for DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 by Diagnostic Chemicals, Ltd. (Usa). It is a Class 2 Microbiology device (product code LIP) cleared through the Traditional 510(k) pathway after a 441-day FDA review.

K895965 · Diagnostic Chemicals, Ltd. (Usa) · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1990
Decision
441d
Days
Class 2
Risk

K895965 is an FDA 510(k) clearance for the DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70. Classified as Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (product code LIP), Class II - Special Controls.

Submitted by Diagnostic Chemicals, Ltd. (Usa) (Oxford, US). The FDA issued a Cleared decision on December 26, 1990 after a review of 441 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Microbiology submissions.

View all Diagnostic Chemicals, Ltd. (Usa) devices

Submission Details

510(k) Number K895965 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date December 26, 1990
Days to Decision 441 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
339d slower than avg
Panel avg: 102d · This submission: 441d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 18
Devices cleared under the same product code (LIP) and FDA review panel - the closest regulatory comparables to K895965.
DIASORIN LIAISON TREPONEMA ASSAY
K061247 · DiaSorin, Inc. · Jul 2006
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
DCL SYPHILIS-M CATALOG NO. 600-80
K895964 · Diagnostic Chemicals, Ltd. (Usa) · Jan 1991
ORTHO* SYPHILIS-M ANTIBODY ELISA TEST
K883938 · Ortho Diagnostic Systems, Inc. · Dec 1988
ORTHO* SYPHILIS-G ANTIBODY ELISA TEST
K883939 · Ortho Diagnostic Systems, Inc. · Dec 1988
CORDIA S4 -TREPONEMA PALLIDUM
K850329 · Cordis Corp. · Jul 1985