Cleared Traditional

K870107 - COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS

K870107 is an FDA 510(k) clearance for COAT-A-COUNT IRMA FERRITIN KIT AND ITS ..., manufactured by Diagnostic Products Corp.. The device is a Class 2 Immunology device with product code DBF cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K870107 · Diagnostic Products Corp. · Immunology device
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Feb 1987
Decision
29d
Days
Class 2
Risk

K870107 is an FDA 510(k) clearance for the COAT-A-COUNT IRMA FERRITIN KIT AND ITS COMPONENTS. Classified as Ferritin, Antigen, Antiserum, Control (product code DBF), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on February 10, 1987 after a review of 29 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 Diagnostic Products Corp. devices

FDA 510(k) Submission Details - K870107

510(k) Number K870107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1987
Decision Date February 10, 1987
Days to Decision 29 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
76d faster than avg
Panel avg: 105d · This submission: 29d
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 73
Devices cleared under the same product code (DBF) and FDA review panel - the closest regulatory comparables to K870107.
CIBA CORNING MAGIC LITE FERRITIN
K873573 · Ciba Corning Diagnostics Corp. · Oct 1987
DSL 5400 ACTIVE (TM) FERRITIN EIA SYSTEM
K871489 · Diagnostic Systems Laboratories, Inc. · Jun 1987
FERRITIN MAB SOLID PHASE COMPONENT SYSTEM
K870570 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1987
BECKMAN EPSILON(TM) FERRITIN TEST KIT
K864437 · Beckman Instruments, Inc. · Jan 1987
TANDEM(R)-M FERRITIN IMMUNOENZYMETRIC ASSAY
K863345 · Hybritech, Inc. · Oct 1986
QUANTIMUNE(R) FERRITIN IRMA
K863487 · Bio-Rad · Oct 1986