Cleared Traditional

K964418 - N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET

K964418 is an FDA 510(k) clearance for N-ASSAY TIA RHEUMATOID FACOTR MULTI-CAL..., manufactured by Kamiya Technology Services. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K964418 · Kamiya Technology Services · Immunology device
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Dec 1996
Decision
73d
Days
Class 2
Risk

K964418 is an FDA 510(k) clearance for the N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Kamiya Technology Services (Westport, US). The FDA issued a Cleared decision on December 13, 1996 after a review of 73 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 Kamiya Technology Services devices

FDA 510(k) Submission Details - K964418

510(k) Number K964418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 01, 1996
Decision Date December 13, 1996
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 105d · This submission: 73d
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 110
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K964418.
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
K962729 · Hycor Biomedical, Inc. · Mar 1997
THERATEST EL-RFSCR
K962050 · Theratest Laboratories, Inc. · Dec 1996
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT
K964415 · Kamiya Technology Services · Dec 1996
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST
K962015 · Teco Diagnostics · Nov 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · Beckman Instruments, Inc. · Nov 1996
QUALITROL RF CONTROLS
K961545 · Consolidated Technologies, Inc. · Sep 1996