Cleared Traditional

CRIT-SCAN II MONITOR (K983551) - FDA 510(k) Clearance

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

K983551 · In-Line Diagnostics Corp. · Hematology device
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May 1999
Decision
230d
Days
Class 2
Risk

K983551 is an FDA 510(k) clearance for the CRIT-SCAN II MONITOR. Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by In-Line Diagnostics Corp. (Farmington, US). The FDA issued a Cleared decision on May 27, 1999 after a review of 230 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5600 - 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 In-Line Diagnostics Corp. devices

Submission Details

510(k) Number K983551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1998
Decision Date May 27, 1999
Days to Decision 230 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
117d slower than avg
Panel avg: 113d · This submission: 230d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKF Instrument, Hematocrit, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5600
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 - GKF Instrument, Hematocrit, Automated

All 14
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K983551.
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160415 · Instrumentation Laboratory CO · Dec 2016
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1987
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199 · United States Surgical, A Division of Tyco Healthc · Feb 1981