Cleared Traditional

K781119 - ECA HEME BUFFER

K781119 is the FDA 510(k) clearance for ECA HEME BUFFER by Electrophoresis Corp. of America. It is a Class 2 Chemistry device (product code JBD) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K781119 · Electrophoresis Corp. of America · Chemistry device
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Aug 1978
Decision
42d
Days
Class 2
Risk

K781119 is an FDA 510(k) clearance for the ECA HEME BUFFER. Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Electrophoresis Corp. of America (Mchenry, US). The FDA issued a Cleared decision on August 14, 1978 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7440 - 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

Submission Details

510(k) Number K781119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1978
Decision Date August 14, 1978
Days to Decision 42 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 88d · This submission: 42d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JBD System, Analysis, Electrophoretic Hemoglobin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7440
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 Chemistry devices follow this clearance model.

Regulatory Peers - JBD System, Analysis, Electrophoretic Hemoglobin

All 21
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K781119.
A,FDA2 LYOPHILIZED HEMO CONTROL
K800856 · Helena Laboratories · Apr 1980
BECKMAN B-4 TEB BUFFER KIT
K791290 · Beckman Instruments, Inc. · Aug 1979
CITRATE AGAR GEL AND BUFFER SET
K790944 · Corning Medical & Scientific · Jun 1979
HBF-QUIPLATE METHODOLOGY
K780807 · Helena Laboratories · Jun 1978
REDI-DISC HEMOGLOBIN GEL TUBE KIT
K780163 · Miles Laboratories, Inc. · Mar 1978
HEMOGLOBIN A2 TESTING SYSTEM
K771649 · Isolab, Inc. · Oct 1977