Cleared Traditional

K780807 - HBF-QUIPLATE METHODOLOGY

K780807 is the FDA 510(k) clearance for HBF-QUIPLATE METHODOLOGY by Helena Laboratories. It is a Class 2 Hematology device (product code JBD) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K780807 · Helena Laboratories · Hematology device
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Jun 1978
Decision
29d
Days
Class 2
Risk

K780807 is an FDA 510(k) clearance for the HBF-QUIPLATE METHODOLOGY. Classified as System, Analysis, Electrophoretic Hemoglobin (product code JBD), Class II - Special Controls.

Submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 2, 1978 after a review of 29 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 Helena Laboratories devices

Submission Details

510(k) Number K780807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1978
Decision Date June 02, 1978
Days to Decision 29 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
84d faster than avg
Panel avg: 113d · This submission: 29d
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 18
Devices cleared under the same product code (JBD) and FDA review panel - the closest regulatory comparables to K780807.
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
REDI-DISC HEMOGLOBIN GEL TUBE KIT
K780163 · Miles Laboratories, Inc. · Mar 1978
HEMOGLOBIN A2 TESTING SYSTEM
K771649 · Isolab, Inc. · Oct 1977