Cleared Traditional

K844158 - STRATUS FERRITIN FLUOROMETRIC ENZYME IM...

K844158 is the FDA 510(k) clearance for STRATUS FERRITIN FLUOROMETRIC ENZYME IM... by American Dade. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K844158 · American Dade · Immunology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
26d
Days
Class 2
Risk

K844158 is an FDA 510(k) clearance for the STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on November 19, 1984 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5340 - the FDA immunology 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 American Dade devices

Submission Details

510(k) Number K844158 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1984
Decision Date November 19, 1984
Days to Decision 26 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 104d · This submission: 26d
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 Immunology devices follow this clearance model.

Regulatory Peers - DBF Ferritin, Antigen, Antiserum, Control

All 62
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K844158.
QUANTIMUNE(R) FERRITIN IRMA
K863487 · Bio-Rad · Oct 1986
IMMPULSE FERRITIN ASSAY REAGENT
K862014 · Sclavo, Inc. · Jun 1986
ENZYMUN-TEST FERRITIN
K860137 · Boehringer Mannheim Corp. · Mar 1986
DSL FERRITIN IRMA
K841925 · Diagnostic Systems Laboratories, Inc. · May 1984
CORNING FERRITIN 125I RADIOIMMUNOASSAY
K830591 · Corning Medical & Scientific · Mar 1983
TANDEM-E -FER IMMUNOENZYMETRIC KIT
K823871 · Hybritech, Inc. · Feb 1983