Cleared Traditional

K902462 - MODIFIED QM300 RHEUMATOID FACTOR TEST

K902462 is the FDA 510(k) clearance for MODIFIED QM300 RHEUMATOID FACTOR TEST by Kallestad Diag, A Div. of Erbamont, Inc.. It is a Class 2 Immunology device (product code DHR) cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K902462 · Kallestad Diag, A Div. of Erbamont, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1990
Decision
17d
Days
Class 2
Risk

K902462 is an FDA 510(k) clearance for the MODIFIED QM300 RHEUMATOID FACTOR TEST. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on June 21, 1990 after a review of 17 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 Kallestad Diag, A Div. of Erbamont, Inc. devices

Submission Details

510(k) Number K902462 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1990
Decision Date June 21, 1990
Days to Decision 17 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
87d faster than avg
Panel avg: 104d · This submission: 17d
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 K902462.
WAKO AUTOKIT RF
K922151 · Wako Chemicals USA, Inc. · Jul 1992
TURBIQUANT
K920124 · Behring Diagnostics, Inc. · Mar 1992
RAPITEX(R) RF NEW
K903852 · Behring Diagnostics, Inc. · Aug 1990
TECHNICON DPA-1 SYSTEM RF METHOD
K894574 · Technicon Instruments Corp. · Aug 1989
REAADS-RF TEST KIT-QUANTITATIVE
K892444 · Biosearch Medical Products, Inc. · Jun 1989
REAADS-RF TEST KIT-SEMIQUANTITATIVE
K892445 · Biosearch Medical Products, Inc. · Jun 1989