Cleared Traditional

K874151 - RF DIPSTICK TEST KIT

K874151 is an FDA 510(k) clearance for RF DIPSTICK TEST KIT, manufactured by Lipogen, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K874151 · Lipogen, Inc. · Immunology device
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Dec 1987
Decision
77d
Days
Class 2
Risk

K874151 is an FDA 510(k) clearance for the RF DIPSTICK TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Lipogen, Inc. (Knoxville, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 77 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 Lipogen, Inc. devices

FDA 510(k) Submission Details - K874151

510(k) Number K874151 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1987
Decision Date December 29, 1987
Days to Decision 77 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 105d · This submission: 77d
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 112
Devices cleared under the same product code (DHR) and FDA review panel - the closest regulatory comparables to K874151.
UBI MAGIWEL RF-IGM QUANTITATIVE
K883355 · United Biotech, Inc. · Sep 1988
QM300 RHEUMATOID FACTOR ANTIGEN PACK
K883536 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
QM300 CALIBRATOR E PACK
K883538 · Kallestad Diag, A Div. of Erbamont, Inc. · Sep 1988
REUMA TEST
K873782 · Sclavo, Inc. · Nov 1987
RHEUMA-CHECK ENZYME IMMUNOASSAY TEST
K871196 · Orion Diagnostica, Inc. · May 1987
RF MICROASSAY
K871041 · Diamedix Corp. · Mar 1987