Cleared Traditional

K851545 - ULTRACLONE ECL-01-800 CELL LINE

K851545 is an FDA 510(k) clearance for ULTRACLONE ECL-01-800 CELL LINE, manufactured by Earl-Clay Laboratories, Inc.. The device is a Class 1 Pathology device with product code KIR cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K851545 · Earl-Clay Laboratories, Inc. · Pathology device
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May 1985
Decision
24d
Days
Class 1
Risk

K851545 is an FDA 510(k) clearance for the ULTRACLONE ECL-01-800 CELL LINE. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Earl-Clay Laboratories, Inc. (Novato, US). The FDA issued a Cleared decision on May 10, 1985 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2280 - the FDA pathology 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 Earl-Clay Laboratories, Inc. devices

FDA 510(k) Submission Details - K851545

510(k) Number K851545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1985
Decision Date May 10, 1985
Days to Decision 24 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 77d · This submission: 24d
Pathway characteristics
Predicate-based equivalence.

KIR Device Classification - Class 1, General Controls

Product Code KIR Cells, Animal And Human, Cultured
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2280
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 - KIR Cells, Animal And Human, Cultured

All 154
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K851545.
MDCK
K852394 · Viromed Laboratories, Inc. · Jul 1985
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K852395 · Viromed Laboratories, Inc. · Jul 1985
HEK
K852396 · Viromed Laboratories, Inc. · Jul 1985
CELL-MATICS HERPES SIMPLEX VIRUS DETECT
K840366 · Difco Laboratories, Inc. · Jan 1985
ULTRAXLONE ECL-01-1000 CELL LINE
K843577 · Earl-Clay Laboratories, Inc. · Oct 1984
ULTRACLONE ECL-01-2100 CELL LINE
K843578 · Earl-Clay Laboratories, Inc. · Oct 1984