Cleared Traditional

K895261 - ABNORMAL COAGULATION CONTROL PLASMA-2 (...

K895261 is the FDA 510(k) clearance for ABNORMAL COAGULATION CONTROL PLASMA-2 (... by Medical Diagnostic Technologies, Inc.. It is a Class 2 Hematology device (product code GGC) cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K895261 · Medical Diagnostic Technologies, Inc. · Hematology device
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Oct 1989
Decision
45d
Days
Class 2
Risk

K895261 is an FDA 510(k) clearance for the ABNORMAL COAGULATION CONTROL PLASMA-2 (ACCP-2). Classified as Control, Plasma, Abnormal (product code GGC), Class II - Special Controls.

Submitted by Medical Diagnostic Technologies, Inc. (Ventura, US). The FDA issued a Cleared decision on October 6, 1989 after a review of 45 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 Medical Diagnostic Technologies, Inc. devices

Submission Details

510(k) Number K895261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 22, 1989
Decision Date October 06, 1989
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 113d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GGC Control, Plasma, Abnormal
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 - GGC Control, Plasma, Abnormal

All 29
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K895261.
ORTHO ABNORMAL PROTEIN C CONTROL PLASMA
K901233 · Ortho Diagnostic Systems, Inc. · Apr 1990
HEPARIN CONTROL PLASMA, FOR USE IN APTT
K900782 · Medical Diagnostic Technologies, Inc. · Mar 1990
ABNORMAL COAGULATION CONTROL PLASMA-1 (ACCP-1)
K895260 · Medical Diagnostic Technologies, Inc. · Oct 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL III
K894425 · Analytical Control Systems, Inc. · Aug 1989
ACS HUMAN PLASMA COAGULATION CONTROL LEVEL II
K893970 · Analytical Control Systems, Inc. · Jul 1989
ACS ANIMAL PLASMA COAGULATION CONTROL LEVEL II
K893971 · Analytical Control Systems, Inc. · Jul 1989