Cleared Traditional

K122553 - MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM

K122553 is an FDA 510(k) clearance for MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM, manufactured by ACON Laboratories, Inc.. The device is a Class 2 Hematology device with product code GKR cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K122553 · ACON Laboratories, Inc. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
349d
Days
Class 2
Risk

K122553 is an FDA 510(k) clearance for the MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by ACON Laboratories, Inc. (San Diego, US). The FDA issued a Cleared decision on August 5, 2013 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122553

510(k) Number K122553 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2012
Decision Date August 05, 2013
Days to Decision 349 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
236d slower than avg
Panel avg: 113d · This submission: 349d
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 32
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K122553.
hemochroma PLUS System
K182298 · Immunostics Inc., · Nov 2018
DiaSpect Tm, DiaSpect Tm Cuvettes
K172173 · Ekf Diagnostic GmbH · Apr 2018
hemochroma PLUS System
K163465 · Immunostics Inc., · Sep 2017
AVIE TOTAL HB TEST SYSTEM
K121752 · Mec Dynamics Corp · Jan 2013
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
K110393 · Ekf Diagnostic GmbH · Mar 2011
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
K090093 · Stanbio Laboratory · Jun 2009
K122553 · MISSION PLUS HB HEMOGLOBIN TESTING SYSTEM
Download PDF FDA Summary ACON Laboratories, In…