Cleared Traditional

K873064 - AMTEC RHEUMATOID FACTOR LATEX AGGLUTINA...

K873064 is the FDA 510(k) clearance for AMTEC RHEUMATOID FACTOR LATEX AGGLUTINA... by Amtec Diagnostics International, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K873064 · Amtec Diagnostics International, Inc. · Immunology device
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Nov 1987
Decision
91d
Days
Class 2
Risk

K873064 is an FDA 510(k) clearance for the AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Amtec Diagnostics International, Inc. (Conroe, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 91 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 Amtec Diagnostics International, Inc. devices

Submission Details

510(k) Number K873064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1987
Decision Date November 04, 1987
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 104d · This submission: 91d
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 85
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K873064.
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
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
SERATEST RF (HEMAGGLUTINATION) KIT
K855221 · Hemagen Diagnostics, Inc. · Apr 1986
RA 80 EIKEN
K854820 · Syn-Kit, Inc. · Jan 1986