Cleared Traditional

HEMOCUE B-HEMOGLOBIN SYSTEM (K961312) - FDA 510(k) Clearance

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

K961312 · Hemocue, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1996
Decision
173d
Days
Class 2
Risk

K961312 is an FDA 510(k) clearance for the HEMOCUE B-HEMOGLOBIN SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Hemocue, Inc. (Potomac, US). The FDA issued a Cleared decision on September 24, 1996 after a review of 173 days - an extended review cycle.

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 Hemocue, Inc. devices

Submission Details

510(k) Number K961312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1996
Decision Date September 24, 1996
Days to Decision 173 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 113d · This submission: 173d
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 38
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K961312.
HemoCue Hb 301 System
K201217 · Hemocue AB · Aug 2020
Hemo Control (optional Add Pack Hemo Control DM)
K200909 · Ekf Diagnostic GmbH · Jun 2020
HemoCue Hb 801 System
K181751 · Hemocue AB · Feb 2019
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995