Cleared Traditional

K863238 - READS RF TEST KIT FOR IGM RHEUMATOID FACTOR

K863238 is an FDA 510(k) clearance for READS RF TEST KIT FOR IGM RHEUMATOID FACTOR, manufactured by Biostar Medical Products, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K863238 · Biostar Medical Products, Inc. · Immunology device
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Oct 1986
Decision
48d
Days
Class 2
Risk

K863238 is an FDA 510(k) clearance for the READS RF TEST KIT FOR IGM RHEUMATOID FACTOR. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Biostar Medical Products, Inc. (Arlington, US). The FDA issued a Cleared decision on October 8, 1986 after a review of 48 days - a notably fast clearance cycle.

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: 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 Biostar Medical Products, Inc. devices

FDA 510(k) Submission Details - K863238

510(k) Number K863238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1986
Decision Date October 08, 1986
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 105d · This submission: 48d
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 112
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K863238.
REUMA TEST
K873782 · Sclavo, Inc. · Nov 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
K871196 · Orion Diagnostica, Inc. · May 1987
RF MICROASSAY
K871041 · Diamedix Corp. · Mar 1987
SERATEST RF (HEMAGGLUTINATION) KIT
K855221 · Hemagen Diagnostics, Inc. · Apr 1986
RA 80 EIKEN
K854820 · Syn-Kit, Inc. · Jan 1986
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · Behring Diagnostics, Inc. · Jun 1985