Cleared Traditional

K771552 - LAS-R RHEUMATOID FACTOR TEST

K771552 is an FDA 510(k) clearance for LAS-R RHEUMATOID FACTOR TEST, manufactured by Hyland Therapeutic Div., Travenol Laboratories. The device is a Class 2 Microbiology device with product code DHR cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K771552 · Hyland Therapeutic Div., Travenol Laboratories · Microbiology device
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Aug 1977
Decision
18d
Days
Class 2
Risk

K771552 is an FDA 510(k) clearance for the LAS-R RHEUMATOID FACTOR TEST. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Hyland Therapeutic Div., Travenol Laboratories (Mchenry, US). The FDA issued a Cleared decision on August 30, 1977 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5775 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hyland Therapeutic Div., Travenol Laboratories devices

FDA 510(k) Submission Details - K771552

510(k) Number K771552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1977
Decision Date August 30, 1977
Days to Decision 18 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
84d faster than avg
Panel avg: 102d · This submission: 18d
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 Microbiology devices follow this clearance model.

Regulatory Peers - DHR System, Test, Rheumatoid Factor

All 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K771552.
RHEUMOGEN TEST SYSTEM
K790012 · Calbiochem-Behring Corp. · Jan 1979
QUANTROLS RF
K771940 · Organon, Inc. · Nov 1977
RHEUMANOSTICON R
K771410 · Organon, Inc. · Sep 1977
TEST, LATEX SLIDE, RHEUMATOID FACTOR
K760036 · Gamma Biologicals, Inc. · Aug 1976
TEST, RHEUM. ARTH., CARD (MACRO-VUE)
K760043 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976