Cleared Traditional

K791008 - ECA (SPECIAL) HEME BUFFER

K791008 is the FDA 510(k) clearance for ECA (SPECIAL) HEME BUFFER by Electrophoresis Corp. of America. It is a Class 2 Hematology device (product code JBD) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K791008 · Electrophoresis Corp. of America · Hematology device
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Aug 1979
Decision
64d
Days
Class 2
Risk

K791008 is an FDA 510(k) clearance for the ECA (SPECIAL) 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 3, 1979 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7440 - the FDA hematology 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: 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 K791008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1979
Decision Date August 03, 1979
Days to Decision 64 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 113d · This submission: 64d
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 Hematology 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 K791008.
A,A2 LYOPHILIZED HEMO CONTROL
K800854 · Helena Laboratories · Apr 1980
A,FSC LYOPHILIZED HEMO CONTROL
K800855 · Helena Laboratories · Apr 1980
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