Cleared Traditional

K922053 - REP SPE PLUS (PONCEAU S) SYSTEM

K922053 is the FDA 510(k) clearance for REP SPE PLUS (PONCEAU S) SYSTEM by Helena Laboratories. It is a Class 1 Chemistry device (product code CEF) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K922053 · Helena Laboratories · Chemistry device
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Aug 1992
Decision
106d
Days
Class 1
Risk

K922053 is an FDA 510(k) clearance for the REP SPE PLUS (PONCEAU S) SYSTEM. Classified as Electrophoretic, Protein Fractionation (product code CEF), Class I - General Controls.

Submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on August 18, 1992 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1630 - the FDA in vitro diagnostics and chemistry 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 Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Helena Laboratories devices

Submission Details

510(k) Number K922053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1992
Decision Date August 18, 1992
Days to Decision 106 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 88d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code CEF Electrophoretic, Protein Fractionation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1630
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEF Electrophoretic, Protein Fractionation

All 19
Devices cleared under the same product code (CEF) and FDA review panel - the closest regulatory comparables to K922053.
BIO-RAD SERUM PROTEINS BY CAPILLARY ELECTROPHORESIS
K963018 · Bio-Rad · Jun 1997
REP 3 FLUR SPE-60 KIT
K964453 · Helena Laboratories · Dec 1996
REP SPE HI-RES TEMPLATE SYSTEM, CAT 3276/3277/3278
K930317 · Helena Laboratories · Aug 1993
REP SPE PLUS (ACID BLUE) SYSTEM,# 3173/3174/3175
K922024 · Helena Laboratories · Jul 1992
BIO-RAD TOTAL PROTEIN TEST KIT
K913315 · Bio-Rad · Jan 1992
REP(R) SPE TEMPLATE 30, 16, & 8
K913807 · Helena Laboratories · Nov 1991