Cleared Traditional

DCL - SYPHILIS-G ASSAY CATALOG NO. 600-70 (K895965) - FDA 510(k) Clearance

Class II Microbiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K895965 · Diagnostic Chemicals, Ltd. (Usa) · Microbiology device
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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
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 34
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