Cleared Traditional

K822657 - EMIT-AMD AMIKACIN ASSAY

K822657 is the FDA 510(k) clearance for EMIT-AMD AMIKACIN ASSAY by Dade Behring, Inc.. It is a Class 2 Chemistry device (product code KLQ) cleared through the Traditional 510(k) pathway after a 25-day FDA review.

K822657 · Dade Behring, Inc. · Chemistry device
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Sep 1982
Decision
25d
Days
Class 2
Risk

K822657 is an FDA 510(k) clearance for the EMIT-AMD AMIKACIN ASSAY. Classified as Radioimmunoassay, Amikacin (product code KLQ), Class II - Special Controls.

Submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on September 28, 1982 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.3035 - 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 Dade Behring, Inc. devices

Submission Details

510(k) Number K822657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1982
Decision Date September 28, 1982
Days to Decision 25 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
63d faster than avg
Panel avg: 88d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KLQ Radioimmunoassay, Amikacin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.3035
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 - KLQ Radioimmunoassay, Amikacin

All 11
Devices cleared under the same product code (KLQ) and FDA review panel - the closest regulatory comparables to K822657.
AMIKACIN ANALYTICAL TEST PACK ACA
K843211 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1984
EMIT QST AMIKACIN ASSAY
K840193 · Syva Co. · Mar 1984
STRATUS AMIKACIN FLUOROMETRIC
K832336 · American Dade · Aug 1983
MACRO-VUE CARD TEST, AMIKACIN
K821771 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1982
COAT-A-COUNT AMIKACIN IRA
K820781 · Diagnostic Products Corp. · Apr 1982
AMES TDA TM AMIKACIN TEST
K811026 · Miles Laboratories, Inc. · Apr 1981