Cleared Traditional

K895964 - DCL SYPHILIS-M CATALOG NO. 600-80

K895964 is an FDA 510(k) clearance for DCL SYPHILIS-M CATALOG NO. 600-80, manufactured by Diagnostic Chemicals, Ltd. (Usa). The device is a Class 2 Microbiology device with product code LIP cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K895964 · Diagnostic Chemicals, Ltd. (Usa) · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
454d
Days
Class 2
Risk

K895964 is an FDA 510(k) clearance for the DCL SYPHILIS-M CATALOG NO. 600-80. 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 January 8, 1991 after a review of 454 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

FDA 510(k) Submission Details - K895964

510(k) Number K895964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1989
Decision Date January 08, 1991
Days to Decision 454 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
352d slower than avg
Panel avg: 102d · This submission: 454d
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 K895964.
COPALIS TREPONEMAL ANTIGEN TOTAL ANTIBODY ASSAY
K992552 · DiaSorin, Inc. · Dec 1999
SYPHILIS IGM HUMAN SERUM CONTROLS
K961317 · Pyramid Biological Corp. · Jun 1996
SYPHILIS IGG HUMAN SERUM CONTROLS
K960493 · Pyramid Biological Corp. · Jun 1996
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