Cleared Traditional

K863114 - PIASTRINIT

K863114 is an FDA 510(k) clearance for PIASTRINIT, manufactured by J. D. Assoc.. The device is a Class 1 Hematology device with product code GGK cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K863114 · J. D. Assoc. · Hematology device
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Nov 1986
Decision
85d
Days
Class 1
Risk

K863114 is an FDA 510(k) clearance for the PIASTRINIT. Classified as Products, Red-cell Lysing Products (product code GGK), Class I - General Controls.

Submitted by J. D. Assoc. (Montclair, US). The FDA issued a Cleared decision on November 6, 1986 after a review of 85 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8540 - 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 J. D. Assoc. devices

FDA 510(k) Submission Details - K863114

510(k) Number K863114 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1986
Decision Date November 06, 1986
Days to Decision 85 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
28d faster than avg
Panel avg: 113d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

GGK Device Classification - Class 1, General Controls

Product Code GGK Products, Red-cell Lysing Products
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8540
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GGK Products, Red-cell Lysing Products

All 15
Devices cleared under the same product code (GGK) and FDA review panel - the closest regulatory comparables to K863114.
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
K874054 · Fisher Scientific Co., LLC · Oct 1987
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
K873348 · Abbott Diagnostics · Sep 1987
HEMOLYSE
K863503 · Reagent Laboratory, Inc. · Oct 1986
NSI LYSING-D REAGENT -4000 ML
K850944 · Nobel Scientific Industries, Inc. · Mar 1985
ACETIC ACID 1% V/V
K842938 · E K Ind., Inc. · Sep 1984
ACETIC ACID, 5% V/V
K842935 · E K Ind., Inc. · Sep 1984