Cleared Traditional

K863345 - TANDEM-M FERRITIN IMMUNOENZYMETRIC ASSAY

K863345 is the FDA 510(k) clearance for TANDEM-M FERRITIN IMMUNOENZYMETRIC ASSAY by Hybritech, Inc.. It is a Class 2 Immunology device (product code DBF) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K863345 · Hybritech, Inc. · Immunology device
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Oct 1986
Decision
40d
Days
Class 2
Risk

K863345 is an FDA 510(k) clearance for the TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Hybritech, Inc. (San Diego, US). The FDA issued a Cleared decision on October 8, 1986 after a review of 40 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 Hybritech, Inc. devices

Submission Details

510(k) Number K863345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1986
Decision Date October 08, 1986
Days to Decision 40 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
64d faster than avg
Panel avg: 104d · This submission: 40d
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 63
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K863345.
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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