Cleared Traditional

K855221 - SERATEST RF (HEMAGGLUTINATION) KIT

K855221 is an FDA 510(k) clearance for SERATEST RF (HEMAGGLUTINATION) KIT, manufactured by Hemagen Diagnostics, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K855221 · Hemagen Diagnostics, Inc. · Immunology device
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Apr 1986
Decision
113d
Days
Class 2
Risk

K855221 is an FDA 510(k) clearance for the SERATEST RF (HEMAGGLUTINATION) KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Hemagen Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on April 22, 1986 after a review of 113 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Hemagen Diagnostics, Inc. devices

FDA 510(k) Submission Details - K855221

510(k) Number K855221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 30, 1985
Decision Date April 22, 1986
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 105d · This submission: 113d
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 111
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K855221.
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
RA 80 EIKEN
K854820 · Syn-Kit, Inc. · Jan 1986
LASER RF CONTROL SERUM-QUALITY CONTROL SERUM
K851537 · Behring Diagnostics, Inc. · Jun 1985
LASER RF TEST -RHEUMATOID FACTOR(S) REAGENTS
K850296 · Behring Diagnostics, Inc. · Apr 1985