Cleared Traditional

K813309 - RA-80 POSITIVE CONTROL

K813309 is an FDA 510(k) clearance for RA-80 POSITIVE CONTROL, manufactured by Sun-Kit. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K813309 · Sun-Kit · Immunology device
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Dec 1981
Decision
23d
Days
Class 2
Risk

K813309 is an FDA 510(k) clearance for the RA-80 POSITIVE CONTROL. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Sun-Kit (Mchenry, US). The FDA issued a Cleared decision on December 17, 1981 after a review of 23 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 - K813309

510(k) Number K813309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 1981
Decision Date December 17, 1981
Days to Decision 23 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
82d faster than avg
Panel avg: 105d · This submission: 23d
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 141
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K813309.
LATEST RF KIT FOR RHEUMATOID FACTOR
K822905 · Fisher Scientific Co., LLC · Oct 1982
RHEUMATOID FACTOR REFERENCE PREPARA.
K821941 · Armkel, LLC · Aug 1982
SERO/TEX RF TEST
K821319 · Texas Immunology, Inc. · May 1982
FIAX RHEUMATOID FACTOR TEST KIT
K812968 · Intl. Diagnostic Technology · Nov 1981
RA LATEX TEST
K812972 · Oxoid U.S.A., Inc. · Nov 1981
RHEUMATEX
K812882 · Armkel, LLC · Oct 1981
K813309 · RA-80 POSITIVE CONTROL
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