Cleared Traditional

K915320 - RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR ...

K915320 is an FDA 510(k) clearance for RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR ..., manufactured by Trinity Laboratories, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 381-day FDA review.

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

FDA 510(k) Submission Details - K915320

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
Combination Product No
PCCP Authorized No
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.

DHR Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DHR System, Test, Rheumatoid Factor

All 103
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K915320.
N LATEX RF
K942328 · Behring Diagnostics, Inc. · Oct 1994
IGM RHEUMATOID FACTOR
K942272 · Immco Diagnostics, Inc. · Sep 1994
EL-RF TEST SYSTEM: EL-RF-IGM KIT
K933712 · Theratest Laboratories, Inc. · Jan 1994
LIQUICHEK RHEUMATOID FACTOR CONTROL
K923578 · Bio-Rad · Oct 1992
WAKO AUTOKIT RF
K922151 · Wako Chemicals USA, Inc. · Jul 1992
TURBIQUANT
K920124 · Behring Diagnostics, Inc. · Mar 1992