Cleared Traditional

ABNORMAL REFERENCE PLASMA-VIII (K895503) - FDA 510(k) Clearance

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

K895503 · Medical Diagnostic Technologies, Inc. · Hematology device
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Oct 1989
Decision
24d
Days
Class 2
Risk

K895503 is an FDA 510(k) clearance for the ABNORMAL REFERENCE PLASMA-VIII. Classified as Plasma, Coagulation Factor Deficient (product code GJT), 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 24 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 K895503 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 12, 1989
Decision Date October 06, 1989
Days to Decision 24 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 113d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GJT Plasma, Coagulation Factor Deficient
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GJT Plasma, Coagulation Factor Deficient

All 28
Devices cleared under the same product code (GJT) and FDA review panel - the closest regulatory comparables to K895503.
FACTOR XI DEFICIENT PLASMA
K900411 · Sigma Chemical Co. · Mar 1990
FACTOR XII DEFICIENT PLASMA
K900412 · Sigma Chemical Co. · Mar 1990
FACTOR II DEFICIENT PLASMA
K900906 · Sigma Chemical Co. · Mar 1990
IMMUNOADSORBED FACTOR VII DEFICIENT PLASMA HUMAN
K880874 · Baxter Healthcare Corp · Mar 1988
FACTOR VIII REFERENCE PLASMA
K880292 · Helena Laboratories · Feb 1988