Cleared Traditional

K172173 - DiaSpect Tm

K172173 is the FDA 510(k) clearance for DiaSpect Tm by Ekf Diagnostic GmbH. It is a Class 2 Hematology device (product code GKR) cleared through the Traditional 510(k) pathway after a 261-day FDA review.

K172173 · Ekf Diagnostic GmbH · Hematology device
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Apr 2018
Decision
261d
Days
Class 2
Risk

K172173 is an FDA 510(k) clearance for the DiaSpect Tm, DiaSpect Tm Cuvettes. Classified as System, Hemoglobin, Automated (product code GKR), Class II - Special Controls.

Submitted by Ekf Diagnostic GmbH (Barleben, DE). The FDA issued a Cleared decision on April 6, 2018 after a review of 261 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 Ekf Diagnostic GmbH devices

Submission Details

510(k) Number K172173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2017
Decision Date April 06, 2018
Days to Decision 261 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
148d slower than avg
Panel avg: 113d · This submission: 261d
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 12
Devices cleared under the same product code (GKR) and FDA review panel - the closest regulatory comparables to K172173.
Hemo Control (optional Add Pack Hemo Control DM)
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hemochroma PLUS System
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IL682, CO-OXIMETER
K945677 · Instrumentation Laboratory CO · Oct 1995
CIBA CORNING MODEL 280 PH/BLOOD GAS SYSTEM
K880353 · Ciba Corning Diagnostics Corp. · Jun 1988