Cleared Traditional

K915320 - RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST (FDA 510(k) Clearance)

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

K915320 · Trinity Laboratories, Inc. · Immunology device
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Dec 1992
Decision
381d
Days
Class 2
Risk

K915320 is an FDA 510(k) clearance for the RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Trinity Laboratories, Inc. (Raleigh, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 381 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5775 - the FDA immunology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Trinity Laboratories, Inc. devices

Submission Details

510(k) Number K915320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date December 07, 1992
Days to Decision 381 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
277d slower than avg
Panel avg: 104d · This submission: 381d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DHR System, Test, Rheumatoid Factor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5775
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 Immunology devices follow this clearance model.