Cleared Traditional

K861585 - ULTRACLONE 01-2300 CELL LINE

K861585 is an FDA 510(k) clearance for ULTRACLONE 01-2300 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 14-day FDA review.

K861585 · Earl-Clay Laboratories, Inc. · Pathology device
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May 1986
Decision
14d
Days
Class 1
Risk

K861585 is an FDA 510(k) clearance for the ULTRACLONE 01-2300 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 13, 1986 after a review of 14 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 - K861585

510(k) Number K861585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date May 13, 1986
Days to Decision 14 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
63d faster than avg
Panel avg: 77d · This submission: 14d
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 K861585.
BUFFALO GREEN MONKEY KIDNEY CELLS
K871613 · Viromed Laboratories, Inc. · May 1987
A549 (HUMAN LUNG CARCINOMA) CULTURE CELLS
K864776 · Bartels Immunodiagnostic Supplies, Inc. · Dec 1986
HUMAN EPITHELOID CERVIX CARCINOMA CELLS (HELA)
K862555 · Viromed Laboratories, Inc. · Jul 1986
ULTRACLONE 01-700 CELL LINE
K861569 · Earl-Clay Laboratories, Inc. · May 1986
HUMAN LUNG CARCINOMA CELLS (A549)
K861373 · Viromed Laboratories, Inc. · Apr 1986
CELLMATIC CHLAMYDIA CULTURE CONFIRM-DIFCO-1000
K860292 · Difco Laboratories, Inc. · Feb 1986