Cleared Traditional

K834391 - IMMUNO-RA

K834391 is an FDA 510(k) clearance for IMMUNO-RA, manufactured by Immunostics Co., Inc.. The device is a Class 2 Microbiology device with product code DHR cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K834391 · Immunostics Co., Inc. · Microbiology device
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Feb 1984
Decision
51d
Days
Class 2
Risk

K834391 is an FDA 510(k) clearance for the IMMUNO-RA. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Immunostics Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on February 3, 1984 after a review of 51 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 Immunostics Co., Inc. devices

FDA 510(k) Submission Details - K834391

510(k) Number K834391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1983
Decision Date February 03, 1984
Days to Decision 51 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 102d · This submission: 51d
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 112
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K834391.
RF TEST KIT
K841454 · Difco Laboratories, Inc. · Apr 1984
SERATEST RF LATEX DETERMINATION
K840863 · Seragen Diagnostics, Inc. · Apr 1984
SOPHEIA MP IGM RHEUMATOID FACTOR EIA
K840049 · Diagnostic Products Corp. · Feb 1984
SERO/TEX RED CELL RF TEST
K831597 · Texas Immunology, Inc. · Jun 1983
RA-CHECK
K831467 · Diagnostic Technology, Inc. · Jun 1983
RHEUMATOID FACTOR-RAPID CARD TEST #65114
K830832 · Emd Chemicals, Inc. · Apr 1983