Cleared Traditional

K981178 - THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS

K981178 is an FDA 510(k) clearance for THROMBOLYTIC ASSESSMENT SYSTEM LOW RANG..., manufactured by Cardiovascular Diagnostics, Inc.. The device is a Class 2 Hematology device with product code GGN cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K981178 · Cardiovascular Diagnostics, Inc. · Hematology device
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Optimized for regulatory review, auditing and printing
Apr 1998
Decision
26d
Days
Class 2
Risk

K981178 is an FDA 510(k) clearance for the THROMBOLYTIC ASSESSMENT SYSTEM LOW RANGE HEPARIN MANAGEMENT TEST CONTROLS. Classified as Plasma, Coagulation Control (product code GGN), Class II - Special Controls.

Submitted by Cardiovascular Diagnostics, Inc. (Raleigh, US). The FDA issued a Cleared decision on April 27, 1998 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5425 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cardiovascular Diagnostics, Inc. devices

FDA 510(k) Submission Details - K981178

510(k) Number K981178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1998
Decision Date April 27, 1998
Days to Decision 26 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
87d faster than avg
Panel avg: 113d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGN Device Classification - Class 2, Special Controls

Product Code GGN Plasma, Coagulation Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5425
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 - GGN Plasma, Coagulation Control

All 91
Devices cleared under the same product code (GGN) and FDA review panel - the closest regulatory comparables to K981178.
SIGMA DIAGNOSTICS ACCUCLOT CONTROL I
K981248 · Sigma Diagnostics, Inc. · Apr 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL II
K981254 · Sigma Diagnostics, Inc. · Apr 1998
SIGMA DIAGNOSTICS ACCUCLOT CONTROL III
K981255 · Sigma Diagnostics, Inc. · Apr 1998
AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2
K980982 · Avocet Medical, Inc. · Apr 1998
CRYO CHECK INR VALIDATION SET
K971219 · Precision Biologicals, Inc. · Aug 1997
CRYO CHECK APC RESISTANT PLASMA
K971222 · Precision Biologicals, Inc. · Aug 1997