Cleared Traditional

K855221 - SERATEST RF (HEMAGGLUTINATION) KIT

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

K855221 · Hemagen Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
9d slower than avg
Panel avg: 104d · This submission: 113d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 84
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K855221.
QM300 CALIBRATOR E PACK
K883538 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
REUMA TEST
K873782 · Sclavo, Inc. · Nov 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