Cleared Traditional

K851432 - HEMOGLOBIN

K851432 is the FDA 510(k) clearance for HEMOGLOBIN by Pointe Scientific, Inc.,. It is a Class 2 Hematology device (product code KHG) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K851432 · Pointe Scientific, Inc., · Hematology device
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Jul 1985
Decision
93d
Days
Class 2
Risk

K851432 is an FDA 510(k) clearance for the HEMOGLOBIN. Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Pointe Scientific, Inc., (Detroit, US). The FDA issued a Cleared decision on July 12, 1985 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pointe Scientific, Inc., devices

Submission Details

510(k) Number K851432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1985
Decision Date July 12, 1985
Days to Decision 93 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
20d faster than avg
Panel avg: 113d · This submission: 93d
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 19
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K851432.
VISION(TM) HEMOGLOBIN
K862202 · Abbott Laboratories · Aug 1986
HEMOGLOBIN REAGENT SET
K860475 · Sterling Diagnostics, Inc. · Mar 1986
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB
K854139 · Eastman Kodak Company · Nov 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