Cleared Traditional

K781118 - ECA BUFFER PH 8.8

K781118 is an FDA 510(k) clearance for ECA BUFFER PH 8.8, manufactured by Electrophoresis Corp. of America. The device is a Class 1 Chemistry device with product code CEF cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K781118 · Electrophoresis Corp. of America · Chemistry device
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Aug 1978
Decision
38d
Days
Class 1
Risk

K781118 is an FDA 510(k) clearance for the ECA BUFFER PH 8.8. Classified as Electrophoretic, Protein Fractionation (product code CEF), Class I - General Controls.

Submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 38 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 Electrophoresis Corp. of America devices

FDA 510(k) Submission Details - K781118

510(k) Number K781118 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 10, 1978
Days to Decision 38 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
50d faster than avg
Panel avg: 88d · This submission: 38d
Pathway characteristics
Predicate-based equivalence.

CEF Device Classification - Class 1, General Controls

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 27
Devices cleared under the same product code (CEF) and FDA review panel - the closest regulatory comparables to K781118.
PARAGON SERUM PROTEIN ELECTROPHORESIS
K802592 · Beckman Instruments, Inc. · Nov 1980
ECA BUFFER, PH 816
K781116 · Electrophoresis Corp. of America · Aug 1978
ECA PREP
K781117 · Electrophoresis Corp. of America · Aug 1978
TRICHLORACETIC ACID 7.5%
K781120 · Electrophoresis Corp. of America · Aug 1978
PONCEAU S
K781123 · Electrophoresis Corp. of America · Aug 1978
AMIDO BLACK CONCENTRATE
K771720 · Sigma Chemical Co. · Nov 1977