Cleared Traditional

K924622 - CYTOQUANT A-549 CELLS

K924622 is the FDA 510(k) clearance for CYTOQUANT A-549 CELLS by Proteins Intl., Inc.. It is a Class 1 Pathology device (product code KIR) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K924622 · Proteins Intl., Inc. · Pathology device
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Dec 1992
Decision
87d
Days
Class 1
Risk

K924622 is an FDA 510(k) clearance for the CYTOQUANT A-549 CELLS, CATALOG #02-201. Classified as Cells, Animal And Human, Cultured (product code KIR), Class I - General Controls.

Submitted by Proteins Intl., Inc. (Rochester Hills, US). The FDA issued a Cleared decision on December 7, 1992 after a review of 87 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 Proteins Intl., Inc. devices

Submission Details

510(k) Number K924622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1992
Decision Date December 07, 1992
Days to Decision 87 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 77d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 79
Devices cleared under the same product code (KIR) and FDA review panel - the closest regulatory comparables to K924622.
CYTOQUANT MRC-5 CELLS 16 X 125 MM TUBE, #01-101
K924619 · Proteins Intl., Inc. · Dec 1992
CYTOQUANT MRC-5 CELLS, CATALOG #03-101
K924620 · Proteins Intl., Inc. · Dec 1992
CYTOQUANT MRC-5 CELLS, CATALOG #02-101
K924621 · Proteins Intl., Inc. · Dec 1992
CYTOQUANT A-549 CELLS, CATALOG #03-201
K924623 · Proteins Intl., Inc. · Dec 1992
CYTOQUANT A-549 CELLS, 16X125 MM TUBE #01-201
K924624 · Proteins Intl., Inc. · Dec 1992
CYTOQUANT HLNFS CELLS, CATLOG #03-151
K924625 · Proteins Intl., Inc. · Dec 1992