Cleared Traditional

K970373 - RAICHEM RHEUMATOID FACTOR SPIA

K970373 is an FDA 510(k) clearance for RAICHEM RHEUMATOID FACTOR SPIA, manufactured by Henage Diagnostics, Inc.. 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.

K970373 · Henage Diagnostics, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
73d
Days
Class 2
Risk

K970373 is an FDA 510(k) clearance for the RAICHEM RHEUMATOID FACTOR SPIA. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Henage Diagnostics, Inc. (Waltham, US). The FDA issued a Cleared decision on April 17, 1997 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 Henage Diagnostics, Inc. devices

FDA 510(k) Submission Details - K970373

510(k) Number K970373 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 1997
Decision Date April 17, 1997
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF
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 K970373.
QUANTA LITE RF IGM
K971614 · Inova Diagnostics, Inc. · Jun 1997
TINAQUANT RHEUMATOID FACTOR ASSAY
K971379 · Boehringer Mannheim Corp. · Jun 1997
SYNCHRON SYSTEMS RHEUMATOID FACTOR (RF) REAGENT, SYNCHRON CX SYSTEMS RF CALIBRATOR
K971788 · Beckman Instruments, Inc. · Jun 1997
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