Cleared Traditional

K822472 - ANTISERA TO HUMAN FERRITIN

K822472 is the FDA 510(k) clearance for ANTISERA TO HUMAN FERRITIN by Kent Laboratories, Inc.. It is a Class 2 Microbiology device (product code DBF) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K822472 · Kent Laboratories, Inc. · Microbiology device

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Sep 1982

Decision

44d

Days

Class 2

Risk

K822472 is an FDA 510(k) clearance for the ANTISERA TO HUMAN FERRITIN. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.5340 - the FDA microbiology 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 Kent Laboratories, Inc. devices

Submission Details

510(k) Number	K822472 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 17, 1982
Decision Date	September 30, 1982
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

58d faster than avg

Panel avg: 102d · This submission: 44d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DBF Ferritin, Antigen, Antiserum, Control
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 866.5340

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 Microbiology devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 63

Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K822472.

CORNING FERRITIN 125I RADIOIMMUNOASSAY

K830591 · Corning Medical & Scientific · Mar 1983

TANDEM-E -FER IMMUNOENZYMETRIC KIT

K823871 · Hybritech, Inc. · Feb 1983

AUTOPAK FERRITIN TEST DELIVERY SYS

K823275 · Micromedic Systems · Dec 1982

FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS

K812786 · Corning Medical & Scientific · Oct 1981

FERRITIN KIT

K812597 · Hybritech, Inc. · Oct 1981

LEECO FERRITIN-QUANT DIAG. TEST KIT

K811880 · Leeco Diagnostics, Inc. · Jul 1981

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K822472

Kent Laboratories, Inc.

Mchenry, IL · US

Regulatory profile

40 submissions 37 cleared

93% clearance rate · Active in Microbiology

Data Intelligence Layer

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Sourced from FDA 510(k) public files . Updated monthly.

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