Cleared Traditional

K923658 - REP IMMUNOFIX

K923658 is the FDA 510(k) clearance for REP IMMUNOFIX by Helena Laboratories. It is a Class 2 Immunology device (product code CFF) cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K923658 · Helena Laboratories · Immunology device
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Nov 1992
Decision
102d
Days
Class 2
Risk

K923658 is an FDA 510(k) clearance for the REP IMMUNOFIX. Classified as Immunoelectrophoretic, Immunoglobulins, (g, A, M) (product code CFF), Class II - Special Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on November 2, 1992 after a review of 102 days - within the typical 510(k) review window.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Immunology review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K923658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 1992
Decision Date November 02, 1992
Days to Decision 102 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 104d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - CFF Immunoelectrophoretic, Immunoglobulins, (g, A, M)

All 16
Devices cleared under the same product code (CFF) and FDA review panel - the closest regulatory comparables to K923658.
SPIFE IFE-6
K973040 · Helena Laboratories · Jan 1998
IMMUNOGLOBULINS G, A & M LIGHT CHAIN SPECIFIC
K924767 · The Binding Site, Ltd. · Feb 1993
IMMUNOGLOBULINS G, A & M AND LIGHT CHAIN SPECIFIC
K924769 · The Binding Site, Ltd. · Feb 1993
REP SPE HI-RES SYSTEM NO. 3176, 3177, 3178
K892424 · Helena Laboratories · Jun 1989
PARAGON IMMUNOELECTROPHORESIS REAGENT
K823884 · Beckman Instruments, Inc. · Mar 1983
CORNING PARAPROTEIN SCREENING
K790667 · Corning Medical & Scientific · Jul 1979