Cleared Traditional

K860137 - ENZYMUN-TEST FERRITIN

K860137 is an FDA 510(k) clearance for ENZYMUN-TEST FERRITIN, manufactured by Boehringer Mannheim Corp.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K860137 · Boehringer Mannheim Corp. · Immunology device
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Mar 1986
Decision
73d
Days
Class 2
Risk

K860137 is an FDA 510(k) clearance for the ENZYMUN-TEST FERRITIN. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Boehringer Mannheim Corp. (Indianapolis, US). The FDA issued a Cleared decision on March 28, 1986 after a review of 73 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 Boehringer Mannheim Corp. devices

FDA 510(k) Submission Details - K860137

510(k) Number K860137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1986
Decision Date March 28, 1986
Days to Decision 73 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
31d faster than avg
Panel avg: 104d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DBF Device Classification - Class 2, Special Controls

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 63
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K860137.
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
K863345 · Hybritech, Inc. · Oct 1986
QUANTIMUNE(R) FERRITIN IRMA
K863487 · Bio-Rad · Oct 1986
IMMPULSE FERRITIN ASSAY REAGENT
K862014 · Sclavo, Inc. · Jun 1986
STRATUS FERRITIN FLUOROMETRIC ENZYME IMMUNOASSAY
K844158 · American Dade · Nov 1984
DSL FERRITIN IRMA
K841925 · Diagnostic Systems Laboratories, Inc. · May 1984
CORNING FERRITIN 125I RADIOIMMUNOASSAY
K830591 · Corning Medical & Scientific · Mar 1983