Cleared Traditional

K832750 - EASYTOUCH HEMOGLOBIN REAGENT

K832750 is the FDA 510(k) clearance for EASYTOUCH HEMOGLOBIN REAGENT by Worthington Diagnostic Systems. It is a Class 2 Chemistry device (product code KHG) cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K832750 · Worthington Diagnostic Systems · Chemistry device
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Sep 1983
Decision
42d
Days
Class 2
Risk

K832750 is an FDA 510(k) clearance for the EASYTOUCH HEMOGLOBIN REAGENT. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Worthington Diagnostic Systems (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 864.7500 - 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 Worthington Diagnostic Systems devices

Submission Details

510(k) Number K832750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1983
Decision Date September 26, 1983
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 KHG Whole Blood Hemoglobin Determination
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7500
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 - KHG Whole Blood Hemoglobin Determination

All 21
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K832750.
HEMOGLOBIN REAGENT SET
K860475 · Sterling Diagnostics, Inc. · Mar 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · Eastman Kodak Company · Nov 1985
HEMOGLOBIN
K851432 · Pointe Scientific, Inc., · Jul 1985
REFEREE BRAND CO-OXIMETER REAGENTS
K830180 · Analytical Products, Inc. · Apr 1983
CORNING 2500 CO-OXIMETER
K830590 · Corning Medical & Scientific · Apr 1983
SERALYZER HEMOGLOBIN REAGENT STRIPS
K822044 · Miles Laboratories, Inc. · Jul 1982