Cleared Traditional

K810221 - SCRIPPSERA THEUMATOID FACTOR REFER. CNTL

K810221 is an FDA 510(k) clearance for SCRIPPSERA THEUMATOID FACTOR REFER. CNTL, manufactured by Scripps-Miles, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K810221 · Scripps-Miles, Inc. · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1981
Decision
13d
Days
Class 2
Risk

K810221 is an FDA 510(k) clearance for the SCRIPPSERA THEUMATOID FACTOR REFER. CNTL. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Scripps-Miles, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 9, 1981 after a review of 13 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.

FDA 510(k) Submission Details - K810221

510(k) Number K810221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1981
Decision Date February 09, 1981
Days to Decision 13 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
92d faster than avg
Panel avg: 105d · This submission: 13d
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 139
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K810221.
RHEUMATOID FACTOR REAGENT TEST KIT
K810306 · Beckman Instruments, Inc. · Mar 1981
RHEUMATOID FACTORS REFERENCE SERUM
K810404 · Calbiochem-Behring Corp. · Mar 1981
SCRIPPSYSTEM RHEUMATOID FACTOR LATEX KIT
K810141 · Scripps-Miles, Inc. · Feb 1981
RA 80 EIKEN KIT DETERM. OF RHEUMATIC F.
K802448 · Syn-Kit, Inc. · Jan 1981
RHEUMATOID FACTOR TEST SYSTEMS
K802688 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1980
AUTOMATED RHEMATOID FACTOR TEST (ARFT)
K800268 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1980
K810221 · SCRIPPSERA THEUMATOID FACTOR REFER. CNTL
Download PDF Scripps-Miles, Inc.