Cleared Traditional

K910745 - HEMOGLOBIN REAGENT

K910745 is the FDA 510(k) clearance for HEMOGLOBIN REAGENT by Toa Medical Electronics USA, Inc.. It is a Class 2 Hematology device (product code GKR) cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K910745 · Toa Medical Electronics USA, Inc. · Hematology device
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Jul 1991
Decision
140d
Days
Class 2
Risk

K910745 is an FDA 510(k) clearance for the HEMOGLOBIN REAGENT. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Toa Medical Electronics USA, Inc. (Los Alamitos, US). The FDA issued a Cleared decision on July 11, 1991 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5620 - 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 Toa Medical Electronics USA, Inc. devices

Submission Details

510(k) Number K910745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1991
Decision Date July 11, 1991
Days to Decision 140 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d slower than avg
Panel avg: 113d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKR System, Hemoglobin, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5620
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 - GKR System, Hemoglobin, Automated

All 19
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K910745.
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
K032482 · Stanbio Laboratory · Oct 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
K023561 · International Technidyne Corp. · Jan 2003
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · Ciba Corning Diagnostics Corp. · Jun 1988
HEMOGLOBIN REAGENT SET
K841057 · Medical Specialties, Inc. · Mar 1984
KING DIAGNOSTICS HEMOGLOBIN TEST
K812127 · King Diagnostics, Inc. · Aug 1981