Cleared Traditional

K961312 - HEMOCUE B-HEMOGLOBIN SYSTEM

K961312 is an FDA 510(k) clearance for HEMOCUE B-HEMOGLOBIN SYSTEM, manufactured by Hemocue, Inc.. The device is a Class 2 Hematology device with product code GKR cleared through the Traditional 510(k) pathway after a 173-day FDA review.

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

FDA 510(k) Submission Details - K961312

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
Combination Product No
PCCP Authorized No
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.

GKR Device Classification - Class 2, Special Controls

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 28
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K961312.
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
BAYER RAPIDPOINT 405 SYSTEM
K020616 · Bayer Diagnostics Corp. · Jul 2002
IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995
AVL OMNI ANALYZER
K954018 · Avl Scientific Corp. · Oct 1995
HEMOGLOBIN REAGENT
K910745 · Toa Medical Electronics USA, Inc. · Jul 1991