Cleared Traditional

ABBOTT VISION HEMOGLOBIN (MODIFICATION) (K953221) - FDA 510(k) Clearance

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

K953221 · Abbott Laboratories · Hematology device
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Sep 1995
Decision
102d
Days
Class 2
Risk

K953221 is an FDA 510(k) clearance for the ABBOTT VISION HEMOGLOBIN (MODIFICATION). Classified as Whole Blood Hemoglobin Determination (product code KHG), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 29, 1995 after a review of 102 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 Abbott Laboratories devices

Submission Details

510(k) Number K953221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1995
Decision Date September 29, 1995
Days to Decision 102 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 113d · This submission: 102d
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 13
Devices cleared under the same product code (KHG) and FDA review panel - the closest regulatory comparables to K953221.
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K221508 · Sanguina, Inc. · Sep 2023
REFLOTRON HEMOGLOBIN TEST TABS
K934064 · Boehringer Mannheim Corp. · Dec 1993
CLINISTAT HEMOGLOBIN REAGENT TEST
K885227 · Heraeus Kulzer, Inc. · Feb 1989
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
K880038 · Sigma Diagnostics, Inc. · Apr 1988
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
K872653 · Em Diagnostic Systems, Inc. · Jul 1987
VISION(TM) HEMOGLOBIN
K862202 · Abbott Laboratories · Aug 1986