Cleared Traditional

CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST (K881068) - FDA 510(k) Clearance

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

K881068 · Creative Laboratory Products, Inc. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
9d
Days
Class 2
Risk

K881068 is an FDA 510(k) clearance for the CLP ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST. Classified as Activated Partial Thromboplastin (product code GFO), Class II - Special Controls.

Submitted by Creative Laboratory Products, Inc. (Indianapolis, US). The FDA issued a Cleared decision on March 23, 1988 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7925 - 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 Creative Laboratory Products, Inc. devices

Submission Details

510(k) Number K881068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 1988
Decision Date March 23, 1988
Days to Decision 9 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 113d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GFO Activated Partial Thromboplastin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7925
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 - GFO Activated Partial Thromboplastin

All 51
Devices cleared under the same product code (GFO) and FDA review panel - the closest regulatory comparables to K881068.
HemosIL Silica Clotting Time
K253957 · Instrumentation Laboratory (IL) Co. · Jan 2026
Cryocheck Hex LA
K193556 · Precision Biologic · Oct 2020
HemosIL Silica Clotting Time
K160445 · Instrumentation Laboratory CO · Mar 2016
HEMOSIL SYNTHASIL
K060688 · Instrumentation Laboratory CO · Apr 2006
HEMOSIL SILICA CLOTTING TIME
K050221 · Instrumentation Laboratory CO · Mar 2005
IL TEST APTT-SP
K973306 · Instrumentation Laboratory CO · Nov 1997