Cleared Traditional

K920753 - RF STAT IGM TEST KIT

K920753 is an FDA 510(k) clearance for RF STAT IGM TEST KIT, manufactured by Biowhittaker Molecular Applications, Inc.. The device is a Class 2 Immunology device with product code DHR cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K920753 · Biowhittaker Molecular Applications, Inc. · Immunology device
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Mar 1992
Decision
40d
Days
Class 2
Risk

K920753 is an FDA 510(k) clearance for the RF STAT IGM TEST KIT. Classified as System, Test, Rheumatoid Factor (product code DHR), Class II - Special Controls.

Submitted by Biowhittaker Molecular Applications, Inc. (Walkersville, US). The FDA issued a Cleared decision on March 30, 1992 after a review of 40 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 - K920753

510(k) Number K920753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1992
Decision Date March 30, 1992
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 105d · This submission: 40d
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 K920753.
PULSE RF TEST
K923771 · Pulse Scientific, Inc. · Oct 1992
ENCORE RHEUMATOID FACTOR EIA
K924056 · Clark Laboratories, Inc. · Sep 1992
WAKO AUTOKIT RF
K922151 · Wako Chemicals USA, Inc. · Jul 1992
HEALTHTEST RHEUMATOID FACTOR ASSAY
K920220 · Akers Research Corp. · Mar 1992
TURBIQUANT
K920124 · Behring Diagnostics, Inc. · Mar 1992
RHEUMAGEN RF T-CONTROL
K904310 · Biokit USA, Inc. · May 1991
K920753 · RF STAT IGM TEST KIT
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