Cleared Traditional

K873064 - AMTEC RHEUMATOID FACTOR LATEX AGGLUTINATION KIT

K873064 is an FDA 510(k) clearance for AMTEC RHEUMATOID FACTOR LATEX AGGLUTINA..., manufactured by Amtec Diagnostics International, Inc.. The device is a Class 2 Immunology device with 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

FDA 510(k) Submission Details - K873064

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
14d faster than avg
Panel avg: 105d · This submission: 91d
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 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
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