Cleared Traditional

COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR (K852317) - FDA 510(k) Clearance

Class II Toxicology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852317 · Roche Diagnostic Systems, Inc. · Toxicology device
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Jun 1985
Decision
25d
Days
Class 2
Risk

K852317 is an FDA 510(k) clearance for the COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR. Classified as Radioimmunoassay, Amikacin (product code KLQ), Class II - Special Controls.

Submitted by Roche Diagnostic Systems, Inc. (Nutley, US). The FDA issued a Cleared decision on June 25, 1985 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 862.3035 - the FDA toxicology 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 Roche Diagnostic Systems, Inc. devices

Submission Details

510(k) Number K852317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 1985
Decision Date June 25, 1985
Days to Decision 25 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 87d · 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 Toxicology devices follow this clearance model.

Regulatory Peers - KLQ Radioimmunoassay, Amikacin

All 19
Devices cleared under the same product code (KLQ) and FDA review panel - the closest regulatory comparables to K852317.
EMIT QST AMIKACIN ASSAY
K840193 · Syva Co. · Mar 1984
EMIT-AMD AMIKACIN ASSAY
K822657 · Dade Behring, Inc. · Sep 1982
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
CYBREX AMIKACIN
K802669 · Abbott Laboratories · Nov 1980
AMIKACIN
K780494 · Diagnostic Products Corp. · Apr 1978