Cleared Traditional

K860475 - HEMOGLOBIN REAGENT SET

K860475 is the FDA 510(k) clearance for HEMOGLOBIN REAGENT SET by Sterling Diagnostics, Inc.. It is a Class 2 Hematology device (product code KHG) cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K860475 · Sterling Diagnostics, Inc. · Hematology device
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Mar 1986
Decision
24d
Days
Class 2
Risk

K860475 is an FDA 510(k) clearance for the HEMOGLOBIN REAGENT SET. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on March 3, 1986 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7500 - 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 Sterling Diagnostics, Inc. devices

Submission Details

510(k) Number K860475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1986
Decision Date March 03, 1986
Days to Decision 24 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
89d faster than avg
Panel avg: 113d · This submission: 24d
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 Hematology devices follow this clearance model.

Regulatory Peers - KHG Whole Blood Hemoglobin Determination

All 20
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K860475.
HAEMOGLOBIN REAGENT - CYANMETHAEMOGLOBIN METHOD
K870363 · Trace Scientific , Ltd. · Mar 1987
TOTAL HEMOGLOBIN
K863104 · J. D. Assoc. · Sep 1986
VISION(TM) HEMOGLOBIN
K862202 · Abbott Laboratories · Aug 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