Cleared Traditional

K961370 - LA POSITIVE CONTROL PLASMA

K961370 is an FDA 510(k) clearance for LA POSITIVE CONTROL PLASMA, manufactured by Medical Diagnostic Technologies, Inc.. The device is a Class 2 Hematology device with product code GGC cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K961370 · Medical Diagnostic Technologies, Inc. · Hematology device
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May 1996
Decision
45d
Days
Class 2
Risk

K961370 is an FDA 510(k) clearance for the LA POSITIVE CONTROL PLASMA. 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 May 24, 1996 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

FDA 510(k) Submission Details - K961370

510(k) Number K961370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1996
Decision Date May 24, 1996
Days to Decision 45 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
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.

GGC Device Classification - Class 2, Special Controls

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 37
Devices cleared under the same product code (GGC) and FDA review panel - the closest regulatory comparables to K961370.
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
K993332 · Gradipore , Ltd. · Feb 2000
COAGULATION CONTROL LEVEL 2 (ABNORMAL)
K984130 · Pacific Hemostasis · Dec 1998
COAGULATION CONTROL LEVEL 3 (ABNORMAL)
K984131 · Pacific Hemostasis · Dec 1998
AT-III CONTROL PLASMA KIT
K955040 · American Bioproducts Co. · Jan 1996
CRYO CHECK LUPUS PLASMA
K952623 · Precision Biologicals, Inc. · Nov 1995
CRYO CHECK ABNORMAL REFERENCE CHECK I & II
K952624 · Precision Biologicals, Inc. · Oct 1995