Cleared Traditional

hemochroma PLUS System (K163465) - FDA 510(k) Clearance

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

K163465 · Immunostics Inc., · Hematology device
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Sep 2017
Decision
270d
Days
Class 2
Risk

K163465 is an FDA 510(k) clearance for the hemochroma PLUS System. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Immunostics Inc., (Ocean, US). The FDA issued a Cleared decision on September 8, 2017 after a review of 270 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 Immunostics Inc., devices

Submission Details

510(k) Number K163465 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2016
Decision Date September 08, 2017
Days to Decision 270 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 113d · This submission: 270d
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 10
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K163465.
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
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · Ciba Corning Diagnostics Corp. · Jun 1988
HEMESPEC II
K803015 · Helena Laboratories · Dec 1980