Cleared Traditional

K911468 - REP SPE PLUS (ACID BLUE) SYSTEM

K911468 is the FDA 510(k) clearance for REP SPE PLUS (ACID BLUE) SYSTEM by Helena Laboratories. It is a Class 1 Chemistry device (product code CEF) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K911468 · Helena Laboratories · Chemistry device
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Apr 1991
Decision
13d
Days
Class 1
Risk

K911468 is an FDA 510(k) clearance for the REP SPE PLUS (ACID BLUE) 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 April 16, 1991 after a review of 13 days - a notably fast clearance cycle.

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: 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 Helena Laboratories devices

Submission Details

510(k) Number K911468 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1991
Decision Date April 16, 1991
Days to Decision 13 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 88d · This submission: 13d
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 K911468.
REP(R) SPE TEMPLATE 30, 16, & 8
K913807 · Helena Laboratories · Nov 1991
REP(TM) SPE TEMP-30-16-8 PROCEDURE, 3170,3171,3172
K913058 · Helena Laboratories · Oct 1991
REP SPE PLUS (PONCEAU S) SYSTEM, 3163, 3164 & 3165
K912386 · Helena Laboratories · Jul 1991
REP SPE PLUS-8 (PONCEAU S) 3165, PLUS-8 NO. 3175
K900251 · Helena Laboratories · Feb 1990
REP TM SPE (PONCEAU S) PROCEDURES
K894585 · Helena Laboratories · Sep 1989
REP SPE-8 KIT, CAT.# 3172/REP SPE-16 KIT CAT.#3171
K893211 · Helena Laboratories · Jun 1989