Cleared Traditional

K811844 - COAT-A-COUNT GENTAMICIN RIA KIT

K811844 is the FDA 510(k) clearance for COAT-A-COUNT GENTAMICIN RIA KIT by Diagnostic Products Corp.. It is a Class 2 Chemistry device (product code DJB) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K811844 · Diagnostic Products Corp. · Chemistry device
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Jul 1981
Decision
9d
Days
Class 2
Risk

K811844 is an FDA 510(k) clearance for the COAT-A-COUNT GENTAMICIN RIA KIT. Classified as Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep. (product code DJB), Class II - Special Controls.

Submitted by Diagnostic Products Corp. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3450 - the FDA in vitro diagnostics and chemistry 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 K811844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1981
Decision Date July 10, 1981
Days to Decision 9 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3450
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 Chemistry devices follow this clearance model.

Regulatory Peers - DJB Radioimmunoassay, Gentamicin (125-i), Second Antibody Sep.

All 13
Devices cleared under the same product code (DJB) and FDA review panel - the closest regulatory comparables to K811844.
AMES TDA SISOMICIN TEST-CONTROL SERUM
K832792 · Miles Laboratories, Inc. · Sep 1983
GENTAMICIN TEST PACK-ACA
K831210 · E.I. Dupont DE Nemours & Co., Inc. · May 1983
AMES TDA GENTAMICIN TEST
K821669 · Miles Laboratories, Inc. · Dec 1982
QUANTIMUNE GENTAMICIN RIA GENTAMICIN
K791770 · Bio-Rad · Oct 1979
FLUOROMATIC GENTAMICIN FIA IMMUNOASSAY
K791547 · Bio-Rad · Oct 1979
BIOASSAY SYSTEM, MS-2 SERUM
K782049 · Abbott Laboratories · Aug 1979