Cleared Traditional

K901859 - COAT-A-COUNT TOTAL IGE IRMA

K901859 is the FDA 510(k) clearance for COAT-A-COUNT TOTAL IGE IRMA by Diagnostic Products Corp.. It is a Class 2 Immunology device (product code JHR) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K901859 · Diagnostic Products Corp. · Immunology device
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May 1990
Decision
9d
Days
Class 2
Risk

K901859 is an FDA 510(k) clearance for the COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2. Classified as Radioimmunoassay, Immunoglobulins (d, E) (product code JHR), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 3, 1990 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.5510 - 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

Submission Details

510(k) Number K901859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1990
Decision Date May 03, 1990
Days to Decision 9 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
95d faster than avg
Panel avg: 104d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JHR Radioimmunoassay, Immunoglobulins (d, E)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.5510
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 - JHR Radioimmunoassay, Immunoglobulins (d, E)

All 7
Devices cleared under the same product code (JHR) and FDA review panel - the closest regulatory comparables to K901859.
IMMILITE TOTAL IGE
K960067 · Diagnostic Products Corp. · Feb 1996
IMMULITE TOTAL IGE
K931703 · Diagnostic Products Corp. · Aug 1993
TURBO-RAST SPECIFIC IGE ASSAY
K903000 · Ventrex Laboratories, Inc. · Jul 1990
ALTERNATE PROCEDURE, PHARMACIA IGE EIA
K882616 · Pharmacia, Inc. · Aug 1988
PHARMACIA IGE EIA
K873077 · Pharmacia, Inc. · Oct 1987