Cleared Traditional

HEMOGLOBIN (K851432) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K851432 · Pointe Scientific, Inc., · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 38
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K851432.
AnemoCheck Home
K221508 · Sanguina, Inc. · Sep 2023
ABBOTT VISION HEMOGLOBIN (MODIFICATION)
K953221 · Abbott Laboratories · Sep 1995
REFLOTRON HEMOGLOBIN TEST TABS
K934064 · Boehringer Mannheim Corp. · Dec 1993
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653 · Em Diagnostic Systems, Inc. · Jul 1987
VISION(TM) HEMOGLOBIN
K862202 · Abbott Laboratories · Aug 1986
CYANMETHEMOGLOBIN TEST
K820596 · Boehringer Mannheim Corp. · Mar 1982